Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.04.2023 – 30.06.2023 Швейцарія

27.06.2023

DH Healthcare GmbH

ORBIS Medication 3.x

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20230626_02

27.06.2023

Randox Laboratories Ltd

Randox Urea assay
Model: UR3825; UR3873; UR8334; UR8070
Lot: see FSN

IVD: Urea IVD, kit, enzyme spectrophotometry

EN-1

Vk_20230621_18

06.06.2023

(Updated 27.06.2023)

Philips Medical Systems

IntelliVue MX40 Patient Monitor
Model: 865350, 865351, 867146, 865352
SW-Version: C.01.59-865350, 865351, 865352; B.06.69-867146

MD: General-purpose multi-parameter bedside monitor

DE-1
FR-1
IT-1
EN-1

Vk_20230605_17

26.06.2023

Johnson & Johnson Surgical Vision Inc.

Veritas Advanced Infusion Packs
Model: VRT-AI & VRT AF
Lot: All Lots

MD: Surgical irrigation/aspiration tubing set

DE-1
FR-1

Vk_20230612_24

23.06.2023

MAQUET Cardiopulmonary GmbH

Rotaflow II drive (flex)
Model: 701074622
S/N: all

Rotaflow II drive (compact)
Model: 701074623
S/N: all

MD: Cardiopulmonary bypass system, roller type

MD: Cardiopulmonary bypass system, roller type

DE-1
EN-1

Vk_20230623_31

23.06.2023

Olympus Winter & Ibe GmbH

HF-resection electrode
Model: See FSN
Lot: See FSN

MD: Electrodes, Electrosurgical

DE-1
EN-1

Vk_20230614_01

23.06.2023

Philips Goldway (Shenzhen) Industrial Inc.

HeartStart Intrepid Monitor/Defibrillator
Model: 867172; N/A
S/N: See CAL2023CCEC009

MD: Rechargeable professional automated external defibrillator

DE-1
FR-1
IT-1

Vk_20230608_19

10.01.2023

(Updated 23.06.2023)

Smiths Medical ASD, Inc.

Administration sets used with CADD pumps
Model: See FSN
Lot: See FSN

Medication cassette reservoirs with Flow Stop
Model: See FSN
Lot: See FSN

MD: Electric infusion pump administration set, single-use

MD: Infusion pump cassette

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20221213_23

09.06.2023

(Updated 22.06.2023)

Philips Medical Systems Nederland B.V

Philips Azurion system
Model: 722010, 722012, 722022, 722023, 722026, 722028, 722033, 722035, 722079, 722224; Not Applicable
Lot: see FSN
S/N: see FSN
SW-Version: Not Applicable

Philips Allura Xper
Model: see FSN
Lot: see FSN
S/N: see FSN

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

DE-1
FR-1
IT-1
EN-1
EN-2

Vk_20230608_18

22.06.2023

Metrax GmbH

PRIMEDIC HeartSave
Model: see FSN
S/N: see FSN

MD: Defibrillators, External, Automated

DE-1
FR-1
IT-1
EN-1

Vk_20230524_29

21.06.2023

Siemens Healthcare GmbH

ARTIS icono / pheno
S/N: ARTIS pheno / icono systems

MD: Stationary angiographic x-ray system, digital

DE-1
IT-1

Vk_20230616_22

08.06.2023

(Updated 21.06.2023)

Altomed Limited

Damato Ruthenium Plaque Template
Model: A7075CIB, A7075CIA, A7075COC
Lot: A7075CIB = 01108, 01301, 01508, 01300. A7075CIA = 01508, 01108, 01300, 01301. A7075COC = 01108, 01107.
SW-Version: n/a

MD: Eye brachytherapy plaque-/applicator-positioning template

DE-1
EN-1

Vk_20230602_24

20.06.2023

GE OEC Medical Systems, Inc.

OEC 9900
S/N: See FSN

OEC Flexiview 8800
S/N: See FSN

OEC 9800
S/N: See FSN

OEC Elite
S/N: See FSN

MD: System, x-ray, fluoroscopic, image-intensified

MD: System, x-ray, fluoroscopic, image-intensified

MD: Stationary angiographic x-ray system, analogue

MD: Mobile general-purpose fluoroscopic x-ray system, digital

DE-1
FR-1
IT-1
EN-1

Vk_20230615_25

20.06.2023

Beckman Coulter Biomedical GmbH

DxA 5000
Model: B50516
S/N: All

IVD: Specimen processing instrument IVD

DE-1
EN-1

Vk_20230614_21

20.06.2023

Medtronic Inc.

Durepair Dura Regeneration Matrix
Model: 61100, 61105, 61106, 61110, 61111

MD: Dura mater graft, bovine

DE-1
FR-1
IT-1

Vk_20230613_26

05.06.2023

(Updated 19.06.2023)

Intersurgical Ltd

Superset Fixed Elbow Catheter Mount 22F-22M/15F
Model: 3502000
Lot: 7220483

MD: Breathing circuit catheter mount, single-use

DE-2
EN-1

Vk_20230530_04

16.06.2023

Datascope Corp.

Cardiosave Intra-Aortic Balloon Pump
Model: 0998-XX-0800-XX; N/A
S/N: All Cardiosave serial numbers distributed March 6, 2012 to present

MD: Intra-aortic balloon pump

DE-1
FR-1
IT-1

Vk_20230612_14

15.06.2023

Olympus Medical Systems Corp.

BF-Series Endoscopes
Model: BF-1TH1100
S/N: All

MD: Flexible video bronchoscope, reusable

DE-1
FR-1
IT-1

Vk_20230508_03

18.04.2023

(Updated 15.06.2023)

Laboratoires Anios

WipAnios Excel
Model: 2446655Y6
Lot: E22807S, E26421S, E14705S, E16614S

MD: Ammonium Salts For The Disinfection Of Medical Devices

DE-2
DE-3
FR-2
FR-3
IT-2
IT-3

Vk_20230413_18

13.04.2023

(Updated 15.06.2023)

Elekta Limited

Elekta Unity
Model: All
S/N: All

MD: Single Energy Linear Accelerators

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20230404_19

12.06.2023

(Updated 14.06.2023)

Thermo Fisher Scientific Oy

Bilirubin Total (DCA)
Model: 981952
Lot: V781, VA38, VB94, W154, W267

IVD: Bilirubin

DE-1
FR-1
IT-1
EN-1

Vk_20230605_04

14.06.2023

Abbott Diagnostics Technologies AS

Afinion 2
Model: see FSN
S/N: see FSN
SW-Version: see FSN

Alere Afinion 2
Model: see FSN
S/N: see FSN
SW-Version: see FSN

IVD: Single-channel clinical chemistry analyser IVD, point-of-care

IVD: Single-channel clinical chemistry analyser IVD, point-of-care

DE-1
DE-1 (User Distr.)
FR-1
FR-1 (User Distr.)
IT-1
IT-1 (User Distr.)

Vk_20230601_06

13.06.2023

Medtronic Inc.

Vanta with AdaptiveStim Technology Primary cell neurostimulator
Model: 977006

AIMD: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

DE-1
FR-1

Vk_20230606_13

13.06.2023

Philips Medizinsysteme Böblingen GmbH

IntelliVue Information Center iX
Model: 866389, 866390
SW-Version: 4.0.1

MD: Centralized patient monitor

DE-1
FR-1
IT-1

Vk_20230522_62

25.04.2023

(Updated 13.06.2023)

Wissner-Bosserhoff GmbH

Pflegebettensystem
Model: sentida 1-6, sentida SC, movita und movita casa
Lot: see FSN

MD: Electrical assistive bed

DE-1
FR-1

Vk_20230419_08

12.06.2023

Spacelabs Healthcare Inc.

Spacelabs Ultraview SL Command Module
Model: 91496

MD: Patient monitoring system module, multifunction

DE-1
FR-1
IT-1
EN-1

Vk_20230531_07

02.06.2023

(Updated 12.06.2023)

TEI Biosciences Inc.

Surgimend
Model: See FSN
Lot: All unexpired lots

PriMatrix
Model: See FSN
Lot: All unexpired lots

MD: Extra-gynaecological surgical mesh, biologic-polymer composite

MD: Collagen wound matrix dressing

DE-1
FR-2
IT-1
EN-1

Vk_20230530_03

09.06.2023

ALLEN MEDICAL SYSTEMS, INC.

Allen Advance Chest Support w/pad
Model: A-71301
S/N: A411534, A430890

MD: Spinal surgery positioning board

DE-1

Vk_20230609_09

08.06.2023

DH Healthcare GmbH

DeepUnity Diagnost
SW-Version: 1.1.0.0 and higher

MD: Picture Archiving And Communication Systems

DE-1
EN-1

Vk_20230601_01

08.06.2023

DH Healthcare GmbH

ORBIS Medication 3.x
SW-Version: 03.17.00.00

MD: General Medicine Instruments – Other

DE-1
EN-1

Vk_20230530_01

07.06.2023

B. Braun Melsungen AG

ProSet Intrafix SafeSet
Model: 4188110
Lot: 23A13FBZ03

MD: Electric infusion pump administration set, single-use

DE-1
FR-1

Vk_20230605_10

07.06.2023

Intuitive Surgical, Inc

EndoWrist Tip-Up Fenestrated Grasper
Model: 470347-12
Lot: All batches manufactured from January 19, 2021 to March 01, 2023.

MD: Robotic surgical forceps, reusable

DE-1
FR-1
IT-1
EN-1

Vk_20230522_51

02.06.2023

(Updated 07.06.2023)

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

BeamAdjust Software
Model: S080032
SW-Version: All

MD: Ionization chamber radiation measuring probe

DE-1
FR-1

Vk_20230516_12

09.05.2023

(Updated 07.06.2023)

Max Mobility LLC

Smartdrive MX2+with Pushtracker E2/E3
Model: MX2-32K, MX2-32P, MX2-32D, MX2-33S, MX2-33P, MX2-33D, MX2-167, MX2-150, MX2-151, MX2-177, MX2-178

MD: Wheelchair electric-motor-driven propulsion system

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1

Vk_20230509_01

06.06.2023

Megadyne Medical Products, Inc

Ethicon Megadyne Electrosurgical Generator
Model: See Attachment 3 – Product Details
Lot: see FSN

MD: Electrosurgical system generator

DE-1
FR-1
IT-1
EN-1

Vk_20230605_25

06.06.2023

Siemens Shanghai Medical Equipment Ltd.

Cios Select
Model: 11515088
S/N: Cios Select VA21 FD systems with Singletank cover assembly -FD.

MD: Portable general-purpose fluoroscopic x-ray system, digital

DE-1
FR-1

Vk_20230602_17

06.06.2023

Qiagen GmbH

QIAstat-Dx Respiratory SARS-CoV-2 Panel
Model: 691214
Lot: 172043034, 172043348, 172043349, 172043369, 172044712, 172046775, 172048091, 172048381, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669

IVD: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-2
FR-2
IT-2

Vk_20230601_22

06.06.2023

bioMérieux

EBV R-GENE
Model: 69-002B
Lot: 1009621440, 1009270270
S/N: N/A
SW-Version: N/A

BK Virus R-GENE
Model: 69-013B
Lot: see FSN

IVD: Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)

IVD: BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

DE-1
EN-1

Vk_20230531_05

23.05.2023

(Updated 02.06.2023)

Teleflex Medical SDN BHD

Basic endotracheal tube
Model: see FSN
Lot: see FSN

MD: Basic endotracheal tube, single-use

DE-1
FR-1
IT-1
EN-1

Vk_20230523_01

23.05.2023

(Updated 02.06.2023)

Hamilton Bonaduz AG

Hamilton CO-RE Tips 50ul, Filter
Model: 235948, 235979, 235697
Lot: see FSN

IVD: Pipette Tips With Filter

DE-1
FR-1
IT-1
EN-1

Vk_20230517_11

01.06.2023

Roche Diabetes Care GmbH

Accu-Chek Solo Diabetes Manager
Model: 07859481001, 07859490001
Lot: All Accu-Chek Solo Data Managers with firmware versions 20.33 or 20.55

MD: General Medicine Therapeutic Treatment Instruments

DE-1.1
DE-1.2
FR-1.1
FR-1.2
IT-1.1
IT-1.2

Vk_20230531_33

09.05.2023

(Updated 01.06.2023)

UFSK-International OSYS GmbH

UFSK-OSYS
Model: 500 XLE
Lot: 15000004, 15000006
S/N: 2000-2999, 3000-4506

MD: General examination/treatment chair, electric

DE-2
FR-2
IT-2
EN-2

Vk_20230503_12

25.04.2023

(Updated 01.06.2023)

ROCAMED

Urology Suction Tubing with Pump Body
Model: SOUR9200ST12
Lot: R006497

MD: Surgical irrigation/aspiration tubing set

FR-1
FR-2

Vk_20230425_17

05.07.2022

(Updated 01.06.2023)

HeartWare Inc.

HeartWare Ventricular Assist System
Model: 1650DE
S/N: All
SW-Version: N/A

AIMD: Implantable ventricular circulatory assist system

DE-1A
DE-1B
DE-2
EN-1A
EN-1B
EN-2

Vk_20220629_24

31.05.2023

Hamilton Bonaduz AG

Hamilton-C1
Model: 161001
SW-Version: 2.2.10

HAMILTON-C2
Model: 160001; 160002; 160008
SW-Version: 2.2.5

HAMILTON-C3
Model: 160005; 160006
SW-Version: 2.0.9

HAMILTON-T1
Model: 161005; 161006; 161009
SW-Version: 2.2.10

MD: Ventilators, Intensive Care

MD: Intensive care ventilator

MD: Neonatal/adult intensive-care ventilator

MD: Ventilators, transport

DE-1
FR-1
IT-1
EN-1

Vk_20230522_63

04.05.2023

(Updated 31.05.2023)

RAL Diagnostics

pH = 7.0 buffer solution for SP automated system
Model: 75050SX5000; 75050SX7010
Lot: L95931; L03933; L13635; L29437; L32938; L34339; L96051; M01201; M41707; M28606; M27506; M27105; M26105; M24905; M17103; M10203; L83648; L62643; L52141; L00732; L86229; L78827

pH = 6.8 buffer solution for SP automated system
Model: 75040SX5000
Lot: L40740; L12035

IVD: Haematology Reagents – Other

IVD: Haematology Reagents – Other

DE-FSN1-v3
DE-FSN2-v2
FR-FSN1-v3
FR-FSN2-v2
IT-FSN1-v3
IT-FSN2-v2
EN-FSN1-v3
EN-FSN2-v2

Vk_20230418_10

30.05.2023

NeuMoDx Molecular Inc.

NeuMoDx Cartridge
Model: 100100
Lot: 117514, 117524, 117528

IVD: Virology – Na Reagents – Other

DE-1
FR-1
IT-1
EN-1

Vk_20230525_13

30.05.2023

Beckman Coulter , Inc.

Access Hybritech p2PSA reagent
Model: A49752
Lot: 234133

IVD: Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

DE-1
EN-1

Vk_20230524_08

30.05.2023

Drägerwerk AG & Co. KGaA

Oxylog 3000 plus
Model: 5704811 and 5704813
S/N: All
SW-Version: n/a

MD: Ventilators, Transport

DE-1
FR-1
IT-1

Vk_20230523_20

30.05.2023

Philips Medical Systems DMC GmbH

MobileDiagnost wDR
Model: 712007, 712006, 712004, 712002

MD: Radiographic unit, mobile

DE-1
FR-1
IT-1
EN-1

Vk_20230523_18

30.05.2023

Gyrus ACMI, Inc.

UroPass Ureteral Access Sheath Set
Model: see FSN
Lot: see FSN

MD: Dilator, Catheter

DE-1
FR-1
IT-1

Vk_20230505_18

09.05.2023

(Updated 30.05.2023)

exocad GmbH

exoplan
Model: 2.3 Matera, 3.0 Galway, 3.1 Rijeka; 4260521365002, 4260521365019, 4260521365026
Lot: A02B03E? ? ? ? , A03B00E? ? ? ? , A03B01E? ? ? ?
SW-Version: 2.3 , 3.0, 3.1

MD: Dental treatment application software

DE-1
FR-1
IT-1
EN-1

Vk_20230505_02

26.05.2023

Cook Endoscopy

Hemospray Endoscopic Hemostat
Model: HEMO-7-EU, HEMO-10-EU, HEMO-7, HEMO-10

MD: Non-organic haemostatic agent

DE-1
FR-1
IT-1

Vk_20230512_02

05.12.2022

(Updated 26.05.2023)

Philips Electronics Nederland B.V.

Philips Ingenia Elition
Model: 781357, 782106, 782137, 781358, 782107, 782119, 782136
S/N: see FSN

MD: Full-body MRI system, superconducting magnet

DE-1
DE-2
DE-3
FR-1
FR-2
FR-3
IT-1
IT-2
IT-3
EN-1

Vk_20221123_04

24.05.2023

NRT Xray A/S

Celex and Intelli-C EU
Model: 03200000, 03200010, 03500000, 03500010

MD: Stationary angiographic x-ray system, digital

DE-1
EN-1

Vk_20230522_37

16.05.2023

(Updated 24.05.2023)

Phadia AB

EliA GBM Well
Model: 14-5514-01, 14-5514-10, 14-5514-41
Lot: All

IVD: Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay

DE-1
FR-1
EN-1

Vk_20230512_16

24.05.2023

Olympus Medical Systems Corp. Shinjuku Monolith

Gastrointestinal Flexible Endoscopes
Model: N3802940, N2551230
S/N: 2964282, 2203050

MD: Flexible video gastroduodenoscope & duodenoscope

FR-1

Vk_20230504_04

24.05.2023

Davol Inc., Subsidiary of C.R. Bard, Inc.

Ventralight ST Mesh with Echo PS
Model: Refer to FSN
Lot: Refer to FSN

MD: Extra-gynaecological surgical mesh, composite-polymer

FR-1
IT-1

Vk_20230426_15

23.05.2023

HeartSine Technologies LLC

HeartSine samaritan PAD
Model: see FSN
Lot: see FSN

MD: Non-rechargeable public semi-automated external defibrillator

DE-1
FR-1

Vk_20230517_13

15.05.2023

(Updated 23.05.2023)

BIÇAKÇILAR TIBBi CiHAZLAR SANAYi VE TiCARET ANONiM SiRKETi

Urimeter 500 Plus

MD: Urine Collection Systems And Bags, Single-use

DE-1
FR-1
IT-1
EN-1

Vk_20230419_23

25.04.2023

(Updated 22.05.2023)

Spiggle & Theis Medizintechnik GmbH

Sterilisation container
Lot: all

Dummy Length Sizer for Middle Ear Implants
Model: 11000-D20, 11000-D25, 11000-D30, 11000-D35, 11000-D40, 11000-D45, 11000-D50, 11000-D55, 11000-D60, 11000-D65, 11000-D70, 11000-D75, 12000-D05, 12000-D10, 12000-D15, 12000-D20, 12000-D25, 12000-D30, 12000-D35, 12000-D40, 12000-D45, and more: see FSN
Lot: all batches

: Sterilization/disinfection container, reusable

MD: Surgical implant template, reusable

DE-1
DE-2
FR-1
FR-2

Vk_20230421_17

18.01.2023

(Updated 22.05.2023)

Siemens Healthcare Diagnostics Inc.

ADVIA Centaur Folate
Model: 10310308, 10325366
Lot: see FSN
S/N: N/A

Atellica IM Folate
Model: 10995572, 10995573
Lot: see FSN
S/N: N/A

IVD: Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

IVD: Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

DE-1 (ADVIA)
DE-1 (Atellica)
FR-1 (ADVIA)
FR-1 (Atellica)
IT-1 (Atellica)

Vk_20230112_14

22.12.2020

(Updated 22.05.2023)

HeartWare Inc.

HeartWare Ventricular Assist System – HVAD Pump Implant Kit
Model: 1104
S/N: all

AIMD: Implantable ventricular circulatory assist system

DE-1
DE-2
DE-3
DE-4
EN-1

Vk_20201218_18

17.05.2023

SEHAR BATOOL International

Single Use Electrosurgical Bipolar Forceps
Model: PINCETTE BIPOLAIRE JEWELLER#5 L115mm POINTE MOUSSE 0.7MM; SB-700-195
Lot: 15042022

MD: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

FR-1

Vk_20230517_14

16.05.2023

(Updated 17.05.2023)

Medtronic Inc.

Cobalt
Lot: N/A
S/N: All

Claria MRI / Amplia MRI / Compia MRI / Viva / Brava CRT-Ds
S/N: All

Cobalt XT
S/N: All

Crome
S/N: All

Visia AF / Visia AF MRI / Evera / Evera MRI ICDs
S/N: All

Primo MRI ICD
S/N: All

Mirro MRI ICD
S/N: All

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Dual-chamber implantable defibrillator

AIMD: Cardiac resynchronization therapy implantable defibrillator

AIMD: Single-chamber / Dual-chamber implantable defibrillator

AIMD: Single-chamber / Dual-chamber implantable defibrillator

AIMD: Single-chamber / Dual-chamber implantable defibrillator

DE-1
FR-1
IT-1
EN-1

Vk_20230510_21

02.05.2023

(Updated 17.05.2023)

FH INDUSTRIE

BEPOD BURR
Model: 256021, 258156, 258157, 264425, 256016, 256017, 256018, 256019, 256020, 258152, 258153, 258154, 258155
Lot: see FSN

MD: Prosthesis Implantation Instruments, Orthopedic

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2

Vk_20230427_19

16.05.2023

Neuromedex GmbH

SECURODRAIN / NeuroVac Silikon-Flachdrainage
Model: 01.3307, 01.3357, 01.3457, 21-0711, 21-0734, 23-0711, 23-0734
Lot: See FSN

MD: Drains, Wound

DE-1
FR-1
IT-1

Vk_20230512_18

16.05.2023

Haelvoet NV

Lago Hospital
Model: 16233
S/N: B22-031680016, B22-031680017, B22-031680018, B22-031680019, B22-031680020, B22-031680021, B22-031680022, B22-031680023, B22-031680024, B22-031680025, B22-031680026, B22-031680027, B22-031680028, B22-031680029, B22-031680030
SW-Version: Not applicable

MD: Hospital/home Care Electric Medical Beds

FR-1

Vk_20230510_07

09.05.2023

(Updated 16.05.2023)

Löwenstein Medical Technology GmbH + Co. KG

LUISA (LM150TD)
Model: 31380-1110
Lot: all
S/N: all

MD: Neonatal/adult intensive-care ventilator

DE-1
FR-1
EN-1

Vk_20230504_08

04.01.2023

(Updated 16.05.2023)

MAQUET Cardiopulmonary GmbH

PLS Set
Model: 701068386, 701068389, 701076706, 701068390
Lot: see Annex I of FSN

HLS Set Advanced
Model: 701069073, 701069076, 701069083, 701069079
Lot: see Annex I of FSN

MD: Cardiopulmonary bypass system blood tubing set

MD: Cardiopulmonary bypass system blood tubing set

DE-1
DE-2
DE-3
DE-4
FR-1
FR-3
FR-4
IT-1
EN-1
EN-2
EN-3
EN-4

Vk_20230103_01

11.05.2023

(Updated 15.05.2023)

Thermo Fisher Scientific Oy

Cascadion SM Clinical Analyzer
Model: 99990000

IVD: Liquid chromatography/mass spectrometry (LC/MS) analyser IVD

DE-1
EN-1

Vk_20230504_12

12.05.2023

Bolton Medical Inc.

TREO Abdominal Stent-Graft System
Model: 08436045397133 / 28-C2-26-070S
Lot: B210423332
SW-Version: N/A

MD: Abdominal aorta endovascular stent-graft

EN-1

Vk_20230504_23

12.05.2023

NEXUS / DIS GmbH

NEXUS / MEDIKATION
SW-Version: 2.8.301

MD: General Medicine Therapeutic Treatment Instruments – Medical Device Software

DE-1

Vk_20230428_08

10.05.2023

Memmert GmbH + Co. KG

INCOmed
Model: INC108med, INC153med, INC246med
S/N: See FSN

MD: Carbon Dioxide Incubators

DE-1
FR-1
IT-1
EN-1

Vk_20230503_10

10.05.2023

Olympus Medical Systems Corp.

SINGLE USE REPOSITIONABLE CLIP HX-202LR/UR
Model: N4508930 – HX-202LR.A QuickClip Pro, N4509030 – HX-202LR.B QuickClip Pro, N4509130 – HX-202UR.A QuickClip Pro, N4509230 – HX-202UR.B QuickClip Pro
Lot: 24K, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK, 31K, 32K

MD: Ligation clip, metallic

DE-1
FR-1

Vk_20230421_16

10.05.2023

Philips Respironics, Inc

Trilogy Evo O2
Model: See FSN

Trilogy EV300
Model: See FSN

Trilogy Evo Universal
Model: See FSN

Trilogy Evo
Model: See FSN

MD: Portable electric ventilator

MD: Portable electric ventilator

MD: Portable electric ventilator

MD: Portable electric ventilator

DE-1
FR-1
IT-1
EN-1

Vk_20230411_02

09.05.2023

NeoDynamics AB

NeoNavia CorePulse probe
Model: 2103
Lot: K23C065

MD: End-cut biopsy gun needle

DE-1

Vk_20230508_16

09.05.2023

MED TRUST Handelsgesellschaft m.b.H.

Wellion LUNA TEST STRIPS 10 GLU
Lot: G20236040

IVD: Glucose monitoring system IVD, home-use

DE-1

Vk_20230426_17

09.05.2023

Abiomed Inc.

Impella 5.5 SmartAssist Heart Pump
Model: 0550-0007; 0550-0002
S/N: 408363, 405946, 406378, 405469, 405947
SW-Version: AIC Software 5.1, 8.2.2, 8.5

MD: Intracardiac circulatory assist axial-pump catheter

DE-1
FR-1
IT-1
EN-1

Vk_20230421_11

04.05.2023

C.R. Bard, Inc.

Magic3 Go Intermittent Silicone Catheter
Model: See FSN
Lot: See FSN

Hydrosil Go Intermittent Silicone Catheter
Model: See FSN
Lot: See FSN

MD: Single-administration urethral drainage catheter

MD: Single-administration urethral drainage catheter

DE-1

Vk_20230428_14

02.05.2023

(Updated 03.05.2023)

Abbott Ireland Diagnostic Division

Alinity i CMV IgM Reagent Kit
Model: 07P4432
Lot: 49341FN00

IVD: Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

DE-1
FR-1
IT-1
EN-1

Vk_20230502_12

03.05.2023

Illumina, Inc

NextSeq 550Dx
Model: 20005715

MiSeqDx Instrument
Model: DX-410-1001, 15036706

IVD: Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

IVD: Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

DE-1
FR-1
IT-1
EN-1

Vk_20230428_13

03.05.2023

Neuromedex GmbH

Medistrip
Model: 01.3200
Lot: see FSN
SW-Version: N/A

MD: Stripper, vein

DE-1
FR-1
IT-1

Vk_20230428_09

02.05.2023

(Updated 03.05.2023)

Abbott Ireland Diagnostic Division

Alinity i Anti-TPO Reagent Kit
Model: 09P3522
Lot: 50321FN00

IVD: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay

DE-1
FR-1
IT-1
EN-1

Vk_20230427_28

11.04.2023

(Updated 02.05.2023)

Huntleigh Healthcare

Sonicaid Team3
Model: All
S/N: All

MD: Foetal/maternal prenatal monitor

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-2

Vk_20230405_11

23.01.2023

(Updated 02.05.2023)

Grena Biomed Limited

NE’X Glue Surgical Adhesive
Model: 0206-NX2, 0206-NX5, 0206-NX10
Lot: Z/220701

MD: Surgical internal adhesive/sealant, animal-derived

DE-1
FR-1
IT-1
EN-1

Vk_20230112_05

08.11.2021

(Updated 01.05.2023)

Instrumentation Laboratory Co.

ACL TOP
Model: 0020302600-0020302601
Lot: see FSN

ACLELITE
Model: 00000880311/00001000311/0000880311R/0001000311R
Lot: see FSN
S/N: 0000880311 all serial numbers below 23012282 0000100031 all serial numbers below 23015246 0000880311R all serial numbers below 11121320R 0001000311R all serial numbers below 16053360R
SW-Version: 04.00.00 or 03.01.04

ACL ELITEPRO
Model: 00000880311/00001000311/0000880311R/0001000311R
Lot: see FSN
S/N: 0000880311 all serial numbers below 23012282 0000100031 all serial numbers below 23015246 0000880311R all serial numbers below 11121320R 0001000311R all serial numbers below 16053360R

ACLElite Ref
Model: 00000880311/00001000311/0000880311R/0001000311R
Lot: see FSN
S/N: 0000880311 all serial numbers below 23012282 0000100031 all serial numbers below 23015246 0000880311R all serial numbers below 11121320R 0001000311R all serial numbers below 16053360R

IVD: Coagulation analyser IVD, laboratory

IVD: Coagulation analyser IVD, laboratory

IVD: Coagulation analyser IVD, laboratory

IVD: Coagulation analyser IVD, laboratory

DE-1
DE-2
DE-3
DE-Rd2
FR-1
IT-1
IT-Ri2
EN-3
EN-Re2

Vk_20211029_18

22.11.2022

(Updated 28.04.2023)

Arrow International Inc

Arrow AutoCAT2 Intra-Aortic Balloon Pump
Model: see FSN
Lot: see FSN
S/N: N/A
SW-Version: N/A

Arrow AC3 Optimus Intra-Aortic Balloon Pump
Model: see FSN
Lot: see FSN

MD: Intra-aortic balloon pump

MD: Intra-aortic balloon pump

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2

Vk_20221117_01

18.04.2023

(Updated 27.04.2023)

BioGnost Ltd.

Cresyl Violet and Luxol Fast Blue Kit
Model: Cresyl Violet: CV-OT-100; Luxol Fast Blue Kit: LFB-100T
Lot: Cresyl Violet: CV-10/21, CV-12/22; Luxol Fast Blue Kit: LFB-14/21, LFB-16/22, LFB-17/22

IVD: Stain Solutions (histology/cytology)

FR-1
EN-1

Vk_20230417_30

18.04.2023

(Updated 27.04.2023)

Medtronic Navigation Inc.

Synergy Cranial, StealthStation Cranial
Model: 9735585, 9735586, 9735587
S/N: All
SW-Version: 3.1.4

MD: Neurological stereotactic surgery system

DE-1
FR-1
IT-1
EN-2

Vk_20230413_08

27.04.2023

SEBIA

A1AT CONTROLS
Model: 4771
Lot: 28022/01, 28022/02

IVD: Alpha-1-antitrypsin (protease inhibitor) IVD, control

DE-1
FR-1
EN-1

Vk_20230412_32

27.04.2023

Olympus Medical Systems Corp.

4K CAMERA HEAD CH-S400-XZ-EB
Model: CH-S400-XZ-EB; N5401750
S/N: All

MD: Endoscope video camera

DE-1
FR-1
EN-1

Vk_20230406_16

26.04.2023

Össur hf.

Icelock Ratchets
Model: L-125000; L-621200; L-621000; L-621100; L-692020
Lot: HF210205, HF210519, HF211008, HF220303, MX210518, MX210816, MX210823, MX211022, MX220316
S/N: N/A
SW-Version: N/A

MD: External lower-limb prosthesis suspensory component, non-powered

DE-1
FR-1
IT-1

Vk_20230420_12

26.04.2023

Hamamatsu Photonics K. K., Systems Division

NanoZoomer
Model: C13210-01, C13220-01, C13220-21MDEU, C16600-21MDEU, C16300-21MDEU
S/N: Please refer to appendix of FSN.
SW-Version: NZAcquire versions 2.0.2 to 3.0.8, or NZAcquireMD

IVD: Other Instruments

DE-1
FR-1
IT-1
EN-1

Vk_20230417_17

12.04.2023

(Updated 26.04.2023)

Siemens Healthcare Diagnostics Inc.

Atellica CH Toxicology Calibrator (TOX Cal)
Model: 11099440
Lot: 74285306, 74536672 and 74732386

IVD: Multiple-type clinical chemistry analyte profile IVD, calibrator

DE-1
FR-1
EN-1

Vk_20230411_01

25.04.2023

Immucor GTI Diagnostics, Inc.

LIFECODES HLA-DQA1/B1 SSO Typing Kit
Model: 628930
Lot: 3012778

IVD: Hla-typing

DE-1
EN-1

Vk_20230424_11

25.04.2023

DePuy MITEK Inc.

Bioknotless Anchor (Arthroscopic)
Model: 212724, 212725, 212726, 212722, 212723
Lot: All lots from January 2020 to present.
SW-Version: N/A

MD: Tendon/ligament bone anchor, bioabsorbable

EN-1

Vk_20230424_01

25.04.2023

GE Healthcare

Centricity PACS
SW-Version: See FSN

Centricity Universal Viewer
SW-Version: See FSN

MD: Radiological PACS software

MD: Medical image management system

DE-1
FR-1
IT-1
EN-1

Vk_20230420_01

25.04.2023

HS Doms GmbH

Ecocentric
S/N: See FSN

HS-810
S/N: See FSN

Sinus
S/N: See FSN

MD: Examination/Treatment Stands, Ophthalmic

MD: Examination/Treatment Stands, Ophthalmic

MD: Examination/Treatment Stands, Ophthalmic

DE-1
FR-1
IT-1

Vk_20230417_21

05.04.2023

(Updated 25.04.2023)

GS Elektromedizinische Geräte G. Stemple GmbH

corpuls3
Model: 04100, 04100.1, 04100.2, 04101, 04200, 04200.1, 04200.2, 04201, 04300, 04300.1, 04300.2, 04301, 04302, 04303, 04304, 04305
SW-Version: 3.2.x, 4.0.x, 4.1.x, 4.2.x, 4.3.0

MD: Physiologic-monitoring defibrillation system

DE-1
FR-1
EN-1

Vk_20230403_12

24.04.2023

Olympus Medical Systems Corp.

Single Use Distal Cover
Model: MAJ-2315, N5786100
Lot: All

MD: Endoscope patient protection cap, single-use

DE-1
FR-1
IT-1

Vk_20230411_51

29.03.2023

(Updated 24.04.2023)

Schiller AG

Tempus LS
Model: 3.940590; 1A.702100
S/N: All serial numbers below 7021.002164 and All serial numbers from 7021.002204 to 7021.002285

MD: Physiologic-monitoring defibrillation system

DE-1
FR-1
IT-1
EN-1
EN-2

Vk_20230327_02

07.03.2023

(Updated 24.04.2023)

Eakin Surgical Limited

Diathermy Suction Devices
Model: S113, S114, S115, S116, S117, S118, S119, S136, S195, S437, S438, S448
Lot: See FSN

MD: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

DE-1
IT-1
EN-1

Vk_20230227_11

22.03.2023

(Updated 21.04.2023)

Stago

STA-R Evolution
SW-Version: 2.90 or 3.02

STA R Max
SW-Version: 2.90 or 3.02

STA Compact
SW-Version: 5.90 or 6.02

STA Compact Max
SW-Version: 5.90 or 6.02

IVD: Haematology analyser, coagulation

IVD: Coagulation analyser IVD, laboratory

IVD: Haematology analyser, coagulation

IVD: Coagulation analyser IVD, laboratory

DE-1
FR-1
IT-1
EN-1

Vk_20230309_01

19.04.2023

B. Braun Melsungen AG

PROSET INFUSION SETs
Model: see FSN
Lot: see FSN

MD: Intravenous line stopcock

DE-1
FR-1
IT-1

Vk_20230418_05

19.04.2023

Resorba Medical GmbH

GENTA-COLL resorb
Model: GC525, GC110
Lot: R00086283, R00087428, R00087448, R00087762

PARASORB RESODONT & PARASORB RESODONT Forte
Model: RD3503, RDF1502, RDF2502, RDF3503, RDF0703
Lot: R00087760, R00087948, R00084416, R00085782, R00085872, R00087871, R00087897, R00088266, R00086281, R00086282, R00087453, R00087484

GENTA-FOIL resorb
Model: GF25, GF1010
Lot: R00088294, R00088461, R00088539

KOLLAGEN resorb
Model: RK9011
Lot: R00088277

MD: Collagen haemostatic agent, antimicrobial

MD: Collagen dental regeneration membrane

MD: Surgical anti-adhesion material, implantable, bioabsorbable, medicated

MD: Collagen haemostatic agent, non-antimicrobial

DE-1

Vk_20230417_26

19.04.2023

Fehling Instruments GmbH & Co. KG

Osteobioptome
Model: NKS-6
Lot: 13J13544, 14C14298, 14D14355, 14F14545, 14F14666, 14G14794, 14J15082, 14K15121, 15H16945, 19M25345, 19M25503, 20L650PE, 20L650PE-1, 22L611TL

MD: Forceps, Biopsy

DE-1
FR-1

Vk_20230417_02

19.04.2023

Beckman Coulter Ireland, Inc.

Bicarbonate
Model: OSR6190, OSR629
Lot: all

IVD: Other Clinical Chemistry

FR-1

Vk_20230414_03

19.04.2023

Philips Healthcare (Suzhou) Co., Ltd.

Incisive CT, CT3500
Model: 728143, 728144, 728148, 728149, 728134
S/N: See FSN

MD: Full-body MRI system, superconducting magnet

FR-1
EN-1

Vk_20230413_19

19.04.2023

Fresenius Kabi AG

Injectomatspritze mit Kanüle
Model: M93000000
Lot: See FSN

Injectomatspritze ohne Kanüle
Model: M93000010
Lot: See FSN

Injectomatspritze orange mit Kanüle
Model: M93000020
Lot: See FSN

MD: Syringe

MD: Syringe

MD: Syringe

DE-1

Vk_20230412_31

14.04.2023

(Updated 19.04.2023)

Iradimed Corporation

1057 MRiduim MRI Infusion Syringe Adapter Set
Model: 1057-50
Lot: 22D15N, 22I17N, 22A03N, 22J46N, 22D58N

MD: Electric infusion pump administration set, single-use

DE-1
FR-1
IT-1
EN-1

Vk_20230406_20

18.04.2023

Datascope Corp.

Cardiosave Intra-Aortic Balloon Pump
Model: 0998-XX-0800-XX
Lot: N/A
S/N: See FSN

MD: Intra-aortic balloon pump

DE-1
FR-1
IT-1

Vk_20230414_13

18.04.2023

Beckman Coulter Inc.

iQ200 Series, DxU 850m and 840m Iris Analyzers
S/N: Windows 10, Software Version 8.1 (iQ200 series), Windows 10, Software Version 8.5, 8.5.1 and 8.6 (DxU)

IVD: Urine analyser IVD, laboratory

DE-1
FR-1
EN-1

Vk_20230414_09

16.03.2023

(Updated 18.04.2023)

MAQUET Cardiopulmonary GmbH

QUADROX-i/-iD Adult/Small Adult/Pediatric/Neonatal
Model: see FSN
Lot: all

VHK 11000
Model: see FSN
Lot: all

MD: Extracorporeal membrane oxygenator

MD: Cardiotomy reservoir

DE-1
DE-2
FR-1
IT-1
EN-1
EN-2

Vk_20230316_17

17.04.2023

STERIS Canada ULC

Reliance Vision Multi-Chamber Washer/Disinfector
Model: N/A
Lot: N/A
S/N: 3611512001, 3607813001

MD: Nephelometers

FR-1

Vk_20230329_19

17.04.2023

Ellex Medical Pty Ltd.

Integre Scan Yellow , Integre Scan Green
Model: LP6Y, LP6G
S/N: ISY0647, ISG0377

MD: Ophthalmic solid-state laser system

EN-1

Vk_20230321_20

17.04.2023

Philips Healthcare Enterprise Imaging Informatics

Spectral CT 7500
Model: 728333; N/A
Lot: N/A
S/N: Refer to the UAL

IQon Spectral CT
SW-Version: N/A

MD: Full-body CT system

MD: Full-body CT system

DE-1
FR-1

Vk_20230321_18

17.04.2023

Tecno Instruments (pvt) Ltd.

Disposable Straight Bipolar Forceps L200mm
Model: P41014010
Lot: 30-07-22

MD: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

FR-1

Vk_20230321_16

14.04.2023

Bioteck S.p.A.

BIO-GEN CORTICAL BONE GRANULES

MD: Bone And Tendon Replacement Devices

EN-1

Vk_20230323_12

29.03.2023

(Updated 14.04.2023)

Philips Medical Systems Nederland B.V

Philips Azurion system
Model: 722063, 722221, 722064, 722222, 722227, 722228, 722067, 722225, 722068, 722226, 722078, 722223, 722079, 722224
SW-Version: R2.2.0, R2.2.1, 2.2.3, R2.2.5 and R2.2.6

MD: Stationary general-purpose fluoroscopic x-ray system, analogue

DE-1
FR-1
IT-1
EN-1

Vk_20230321_19

21.03.2023

(Updated 13.04.2023)

Philips Medizinsysteme Böblingen GmbH

EARLYVUE VS30 VITAL SIGNS MONITOR AND EARLYVUE VS3
Model: 863359, 863380
S/N: see FSN
SW-Version: A.00.02 and A.00.01

MD: General-purpose multi-parameter bedside monitor

DE-1
FR-1
IT-1
EN-1

Vk_20230315_20

28.02.2023

(Updated 13.04.2023)

Elekta, Inc.

Monaco RTP System
SW-Version: Version 5.11, 5.11.01, 5.11.02, 5.11.03

MD: Radiation therapy software

DE-1
FR-1
EN-1

Vk_20230223_16

12.04.2023

Synovis Micro Companies Alliance

NEUROTUBE, 02X40, RP, CE
Model: 531101240010 (GEM0240NT)
Lot: 19012112

MD: Nerve guide, bioabsorbable, synthetic

DE-1

Vk_20230405_10

28.03.2023

(Updated 12.04.2023)

William A. Cook Australia Pty. Ltd.

Bifurcated Iliac Sidebranch Endovascular Graft
Model: G38048

Zenith Branch Endovascular Graft – Iliac Bifurcation
Model: ZBIS-10-45-41, G38612

MD: Synthetic vascular graft

MD: Synthetic vascular graft

DE-1
FR-1
IT-1
EN-1

Vk_20230323_10

12.04.2023

TRUSETAL VERBANDSTOFFWERK GMBH

TRU-PACK surgical procedure kits
Model: see enclosed list
Lot: see enclosed list

MD: Ophthalmic surgical procedure kit, non-medicated, single-use

DE-1
FR-1
IT-1
EN-1

Vk_20230317_10

12.04.2023

Scewo AG

Scewo Bro
SW-Version: Software version number lower than 22.9.3

MD: Electric Wheelchairs

DE-1
EN-1

Vk_20230313_25

03.04.2023

(Updated 12.04.2023)

Tandem Diabetes Care, Inc.

t:slim X2 Insulin Pump with Control-IQ Technology
Model: 1005611
SW-Version: 7.4.3 or lower

t:slim X2 with Basal-IQ Technology
Model: 1006419
SW-Version: 6.4.1 or lower

MD: Ambulatory insulin infusion pump, electronic

MD: Ambulatory insulin infusion pump, electronic

DE-2-HCP
DE-2-User
FR-2-HCP
FR-2-User
IT-2-HCP
IT-2-User
EN-2-HCP
EN-2-User

Vk_20230223_21

28.10.2022

(Updated 12.04.2023)

Boston Scientific Corporation

ORISE Gel Submucosal Lifting Agent
Model: M00519200, M00519201, M00519210, M00519211, M00519220, M00519221, M00519230, M00519231, M00519380, M00519390, M00519400
Lot: all

MD: Submucosal lift solution

DE-1
DE-2
DE-3
FR-1
FR-2
FR-3
IT-1
IT-2
IT-3
EN-1

Vk_20221010_12

11.04.2023

Balanced Body Inc

Reformer models with and without towers

MD: Pilates reformer exerciser

DE-1
FR-1
IT-1

Vk_20230411_15

11.04.2023

Möller Medical GmbH

Drainage Set LiquoGuard 7
Model: 00003501 1411
Lot: AUE115, AXC843, AXY401, AYJ829, AYJ849, AZB143, AZB144, AZD848, AZF324, AZQ420, AZQ421, AZR977, AZX892, AZX893, AZX897

MD: Vacuum And Gravity Drainage Systems – Other

DE-1

Vk_20230411_14

31.03.2023

(Updated 11.04.2023)

In2Bones SAS

I.B.S-C Compression screws
Model: S30 ST128 ; S25 ST024 ; S25 ST026
Lot: See FSN

MD: Orthopaedic bone screw, non-bioabsorbable, sterile

DE-1
FR-1
IT-1
EN-1

Vk_20230324_01

10.03.2023

(Updated 11.04.2023)

Tridentify AB

QTA Tracer 2.0
SW-Version: 2.0.2 and 2.0.3

MD: Medical product temperature point indicator, electronic

EN-1
EN-2

Vk_20230307_01

04.04.2023

(Updated 06.04.2023)

Diagnostic Grifols SA

Erytra Eflexis
Model: 210600
SW-Version: 3.0.0

IVD: Blood group/antibody screening analyser IVD

DE-1
FR-1
EN-1

Vk_20230403_13

05.04.2023

(Updated 06.04.2023)

Fehling Instruments GmbH & Co. KG

CEBOTARI universal sternal retractor
Model: MQL-1

MD: Spreaders

FR-1
FR-2

Vk_20230331_17

06.04.2023

(Updated 06.04.2023)

Medartis AG

Orbital Retractor, left.
Model: M2-2122
Lot: 19200838, 20231589

Orbital Retractor, right.
Model: M2-2121
Lot: 19200836, 20231588

MD: Osteosynthesis Instruments, Reusable – Other

MD: Osteosynthesis Instruments, Reusable – Other

DE-1
FR-1
EN-1

Vk_20230329_17

06.04.2023

Phoenix s.r.l

Volumed Silicone Set
Model: APSPK0J
Lot: 21PH822

MD: Infusion Pump Controllers

DE-1
FR-1
EN-1

Vk_20230328_13

06.04.2023

Olympus Corporation of the Americas

ViziShot 2 Single Use Aspiration Needle
Model: EGNA-U401SX4021, EGNA-U401SX4022
Lot: See FSN
S/N: All

MD: Body aspiration needle, single-use

DE-1
FR-1
IT-1

Vk_20230327_04

21.03.2023

(Updated 06.04.2023)

MANI, INC.

MANI Trocar Kit
Model: MTK23S, MTK25S, MTK27S
Lot: Refer to the Appendix1 attached to FSN
S/N: N/A
SW-Version: N/A

MD: Ophthalmic cannulation set, reusable

DE-1
FR-1
IT-1
EN-1

Vk_20230310_12

06.04.2023

EKU Elektronik GmbH

NO-Applikationsgerät
Model: NO-A

MD: Nitric oxide delivery unit, system-based

DE-2

Vk_20230306_17

21.09.2021

(Updated 06.04.2023)

Medtronic Inc.

Activa Clinician Programmer Application
Model: A610
Lot: n/a
S/N: all
SW-Version: 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081

AIMD: Multiple active implantable device programmer

DE-1
DE-2
FR-1
FR-2
IT-1
IT-2
EN-1
EN-3

Vk_20210916_11

05.04.2023

Drägerwerk AG & Co. KGaA

Seattle PAP plus
Model: MP02260

Neo Einweg-Atemschlauchsysteme
Model: see FSN

Koaxialbeatmungsschläuche
Model: see FSN

Pädiatrie Einweg-Atemschlauchsysteme
Model: see FSN

Set2Go & Pack2Go
Model: see FSN

MD: Tubing

MD: Tubing

MD: Tubing

MD: Tubing

MD: Tubing

DE-1
FR-1
IT-1

Vk_20230403_08

15.03.2023

(Updated 04.04.2023)

Philips Respironics, Inc

Trilogy Evo O2
Model: see FSN

Trilogy EV300
Model: see FSN

MD: Portable electric ventilator

MD: Portable electric ventilator

DE-1
FR-1
IT-1
EN-1

Vk_20230310_01