Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.03.2020 – 30.04.2020

29.04.2020 

(Updated 01.05.2020)

Bentley InnoMed GmbH

BeGraft Coronary Stent Graft System
Model: BG18300, BG21300, BG24300
Lot: BG18300: 208374, 208523, 209016, 209377, 209490, 209824, BG21300: 209176, 209901, BG24300: 208275, 208972, 209387, 209900

MD: Mesh-sleeve coronary artery stent

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

Vk_20200422_09

30.04.2020

Siemens Healthcare GmbH; Business Area Advanced Therapies

Artis icono
Model: See FSN

MD: Stationary angiographic x-ray system, digital

DE-1

Vk_20200427_05

30.04.2020

GS Elektromedizinische Geräte G. Stemple GmbH

Battery corpuls cpr
Model: 09120
Lot: diverse
S/N: diverse

MD: Secondary battery

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

Vk_20200423_08

30.04.2020

Dr. J Hänsler GmbH

OZONOSAN Germ Stop Transfer Filter Set
Model: OZONOSAN Keimstop ; / 3035
Lot: M109921, M110921 M101922, M101928, M101935, M101940 and M103003

MD: Filters, Bacteria

DE-1
IT-1
EN-1

Vk_20200422_11

28.04.2020 

(Updated 30.04.2020)

Medion Grifols Diagnostics AG

Reverse-Cyte 0.8% A1, A2, B, 0
Model: 213588, 213591, 213592, 213593, 213594, 213598
Lot: 630020007, 630120007, 630220007, 630320007, 630420007, 630520007

IVD: ABO grouping cell kit

DE-1
FR-1
EN-1

Vk_20200421_13

07.04.2020 

(Updated 30.04.2020)

Gambro Lundia AB

PrisMax Hemodialysis Machine
Model: 955558

Prismaflex System
Model: 107493, 113082, 113874, 114489, 114870, 955052

MD: Haemodialysis system, institutional

MD: Haemodialysis system, institutional

DE-1
FR-1
EN-1

Vk_20200402_13

29.04.2020

DiaSys Diagnostic Systems GmbH

Creatinine FS

Creatinine PAP FS

Bilirubin Auto Total FS

Bilirubin Auto Direct FS

IVD: Creatinine kit

IVD: Creatinine kit

IVD: Bilirubin kit

IVD: Substrates

DE-1
FR-1
EN-1

Vk_20200424_10

28.04.2020

Schiller AG

medilogAR
Model: 1A.306000
S/N: up to s/n: 3060.0002021

MD: Electrocardiographic ambulatory recorder

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

Vk_20200424_08

28.04.2020

Radiometer Medical ApS

ABL80 FLEX CO-OX
Model: 393-839, 393-841
SW-Version: 3.21 and below

IVD: Metabolic profile clinical chemistry analyser IVD, portable, automated

EN-1

Vk_20200424_02

23.04.2020

Siemens Healthcare GmbH; Business Area Advanced Therapies

Cios Spin
Model: see FSN
S/N: see FSN

Cios Alpha
Model: see FSN
S/N: see FSN

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

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

DE-1
FR-1

Vk_20200420_07

27.03.2020 

(Updated 23.04.2020)

Aesculap AG

Various surgical instruments for use at the central nervous system
Model: see Anhang FSN
Lot: see Anhang FSN

MD: surgical instruments for use at the central nervous system

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

Vk_20200311_17

15.04.2020 

(Updated 22.04.2020)

Radiometer Medical ApS

AQT90 FLEX Analyzers
Model: 393-838
SW-Version: 8.12.380.0 or below

IVD: Fluorescent immunoassay analyser (FIA), stationary

DE-1
FR-1
EN-1

Vk_20200408_21

22.04.2020

HeartWare Inc.

HeartWare Ventricular Assist System - HVAD Pump Implant Kit
Model: 1104, 1125, 1153
S/N: all

AIMD: Artificial heart, temporary

DE-1
EN-1

Vk_20200408_03

21.04.2020

Philips Medical Systems Nederland BV

Philips Azurion 7 M20
Model: 722079
SW-Version: Azurion release 2.0

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

DE-1
EN-1

Vk_20200417_05

21.04.2020

Organ Assist

Liverassist
Model: 11.01.101
Lot: 111804M108, 111804M109

MD: General-purpose donor-organ preservation/transport system

EN-1

Vk_20200416_08

14.04.2020 

(Updated 21.04.2020)

Siemens Healthcare Diagnostics Products GmbH

Coagulation Factor V Deficient Plasma
Model: ORSM19; SMN 10446269
Lot: 504974

IVD: Coagulation factor V IVD, reagent

DE-1
FR-1
EN-1

Vk_20200414_04

21.04.2020

Valoc AG

Adapter Optiloc for handpiece, length 26mm
Model: 170.1
Lot: 17.93403, CH103888, CH103889, CH109608, CH111240, CH112666, CH112735, CH114073, CH115834, CH118133, CH121025, CH127520

MD: Surgical screwdriver, reusable

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

Vk_20200406_16

17.04.2020

Siemens Healthcare Diagnostics Products GmbH

Dade Actin Activated Cephaloplastin Reagent
Model: B4218-2; SMN 10445711
Lot: 557288A
S/N: n/a

IVD: Activated partial thromboplastin time (APTT) IVD, reagent

FR-1
EN-1

Vk_20200414_05

16.04.2020

Elitech Clinical Systems SAS

ELITech RHEUMATOID FACTOR
Lot: All

IVD: Rheumatoid factor IVD, kit, nephelometry/turbidimetry

EN-1

Vk_20200414_03

16.04.2020

Ivoclar Vivadent AG

IPS e.max ZirCAD CER/inLab LT A1-A3 C17/5
Model: 686193, 686194, 686195, 686282EN
Lot: Y48711; Y47472, Z000V0; Y38637, Y47754, Y52136; Y49356, Z006HV, Z0007Z, Z000KK
S/N: N/A

MD: Dental appliance fabrication material, ceramic

DE-1
FR-1
IT-1

Vk_20200406_02

16.04.2020

Natus Medical Denmark, GN Otometrics A/S

Aircal
Model: 8-04-13310, 8-04-13321, 8-04-13322;8-04-13310, 8-04-13321, 8-04-13322
S/N: 1809716, 1812187, 1811633, 1927710, 1927711, 1828101, 1931712, 1829507, 1829508, 1809718, 1809717, 1911447, 1807000, 1927657, 1927658, 1927659
SW-Version: NA

MD: Caloric vestibular-stimulation system

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

Vk_20200330_01

15.04.2020

Elekta, Inc.

Monaco RTP System
Model: N/A
Lot: N/A
S/N: N/A
SW-Version: Version 5.40 and 5.40.1

MD: Radiation therapy software

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

Vk_20200407_09

31.03.2020 

(Updated 15.04.2020)

GCE s.r.o.

Combilite Valve
Model: all versions
Lot: all
S/N: all

MD: Valve

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

Vk_20200311_18

14.04.2020

Fast-Track Diagnostics S.a.r.l.

FTD Vesicular rash
Model: FTD-7-32/10921714, FTD-7-64/10921715
Lot: All lot numbers

IVD: Multiple meningitis-associated microorganism nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Vk_20200414_01

14.04.2020

Spectranetics Corporation

Bridge Occlusion Balloon
Model: 590-001
Lot: Not batch number specific
S/N: Not serial number specific

MD: Intravascular occluding balloon catheter, image-guided

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

Vk_20200409_23

14.04.2020

Qiagen GmbH

therascreen EGFR RGQ PCR Kit (24)
Model: 874111
SW-Version: RGQ therascreen EGFR CE Assay Package CD, v3.0.5

therascreen EGFR Plasma RGQ PCR Kit (24)
Model: 870311
SW-Version: RGQ therascreen EGFR CE Assay Package CD, v3.0.5

IVD: Other Acquired Gene or Chromosome Alteration Tests

IVD: Other Acquired Gene or Chromosome Alteration Tests

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

Vk_20200408_15

11.03.2020 

(Updated 14.04.2020)

RaySearch Laboratories AB

RayStation
Model: see FSN

MD: Radiation therapy software

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

Vk_20200304_14

13.04.2020

Inpeco S.A.

Aptio Automation
Model: see FSN
SW-Version: see FSN

IVD: Specimen processing instrument IVD, automated

DE-1
EN-1

Vk_20200324_03

25.03.2020 

(Updated 13.04.2020)

Inpeco S.A.

ACCELERATOR a3600
Model: see FSN
SW-Version: see FSN

IVD: Specimen processing instrument IVD, automated

FR-1
EN-1

Vk_20200324_02

25.03.2020 

(Updated 13.04.2020)

Inpeco S.A.

FlexLab
Model: see FSN
SW-Version: see FSN

IVD: Specimen processing instrument IVD, automated

DE-1
EN-1

Vk_20200324_01

09.04.2020

Beckman Coulter Ireland, Inc.

iChemVELOCITY Automated Urine Chemistry System
Model: 700-7176-001, 700-7177-001, 700-7087
Lot: Not applicable

iQ200 Series Urine Microscopy Analyzer
Model: 700-3345, 700-3375, 700-3325, 700-3347, 700-3326, 700-3370, 700-3320, 700-3322, 700-3340, 700-3320RFB, B48999, 700-3376.
Lot: Not applicable

IVD: Urine analyser IVD, laboratory, automated

IVD: Urine analyser IVD, laboratory, automated

DE-1
EN-1

Vk_20200407_01

09.04.2020

Biomet Orthopedics

Comprehensive
Model: 110028522
Lot: 494350, 494350R, 233080, 364910, 489000, 079630, 516230, 742760, 362370, 465800, 197900, 175110, 175100
SW-Version: N/A

MD: Orthopaedic implant inserter/extractor, reusable

DE-1

Vk_20200402_11

07.04.2020

Synaptive Medical Inc

ClearCanvas RIS/PACS
Model: SYN-0524
S/N: All ClearCanvas RIS/PACS serial numbers distributed 2011-04-21 to 2019-11-26
SW-Version: 3.0 and higher

MD: Radiology PACS software

DE-1
FR-1
IT-1

Vk_20200327_02

07.04.2020

LeMaitre Vascular, Inc.

LeMaitre Over-the-Wire Embolectomy Catheters
Model: 1651-84, 1651-88
Lot: See FSN
S/N: N/A
SW-Version: N/A

MD: Thrombectomy balloon catheter

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

Vk_20200325_04

07.04.2020

Smith & Nephew, Inc.

Footprint Ultra PK Suture Anchor
Model: 72202901 and 72202902
Lot: Please see FSN.

MD: Ligament bone anchor

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

Vk_20200325_03

26.03.2020 

(Updated 06.04.2020)

EUROIMMUN Medizinische Labordiagnostika AG

Anti-Zika-Virus-ELISA (IgG)
Model: EI 2668-9601 G
Lot: E190109BY

IVD: Other Viral Antigen/Antibody Detection

DE-1
EN-1

Vk_20200318_08

05.02.2020 

(Updated 06.04.2020)

Siemens Healthcare Diagnostics Inc.

Atellica CH 930 Reaction Cuvette Segment
Model: SMN 11099326
Lot: see FSN
S/N: N/A

IVD: Laboratory analyser cuvette IVD, reusable

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

Vk_20200128_08

31.03.2020 

(Updated 02.04.2020)

Smiths Medical ASD, Inc.

CADD-Solis Ambulatory Infusion Pump
Model: 21-2120-0105-02L, 21-2120-0105-03L, 21-2120-0105-06L, 21-2120-0105-07L, 21-2120-0105-08L, 21-2120-0105-12L, 21-2120-0105-13L, 21-2120-0105-14L, 21-2120-0105-15L, 21-2120-0105-17L, 21-2120-0105-50L, 21-2127-0105-02L, 21-2127-0105-06L, 21-2127-0105-50L
S/N: Please Refer to Attached Device List

MD: General-purpose infusion pump, line-powered

DE-1
FR-1
IT-1
EN-1
EN-device list

Vk_20200325_01

20.03.2020 

(Updated 02.04.2020)

Welch Allyn Inc

Cable Leads
Model: see FSN

S4, T12, X12+
Model: see FSN

ELI devices, RScribe, ELI PC
Model: see FSN

H12+
Model: see FSN

S12/S19
Model: see FSN

Q-Stress
Model: see FSN

Xscribe
Model: see FSN

MD: Electrocardiographic lead set, reusable

MD: Electrocardiography telemetric monitoring system transmitter

MD: Electrocardiograph, professional, multichannel

MD: Electrocardiographic ambulatory recorder

MD: Multiple-patient intensive/general healthcare physiologic monitoring system

MD: Stress exercise monitoring system computer

MD: Cardiac stress exercise monitoring system

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

Vk_20200316_04

01.04.2020

Philips Medical Systems Nederland BV

Philips Azurion system
Model: Azurion 7 M20 systems, 722079

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

DE-1
EN-1

Vk_20200327_04

01.04.2020

Vascular Solutions Inc.

Langston Dual Lumen Catheter
Model: 5540
Lot: see FSN

MD: Angiographic catheter, single-use

DE-1
FR-1
EN-1

Vk_20200326_02

31.03.2020

Boston Scientific Corporation

GreenLight MoXy Fiber Optic
Model: 0010-2400

MD: Urogenital surgical laser system beam guide, single-use

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

Vk_20200331_01

31.03.2020

Merit Medical Systems, Inc.

PreludeSYNC DISTAL
Model: SDRB-REG-LT; SDRB-REG-RT
Lot: H1559517; H1727668; H1666548; H1723973

MD: Vascular compressor, external

DE-1

Vk_20200330_02

25.03.2020 

(Updated 31.03.2020)

Abbott Diagnostics Technologies AS

Alere Afinion 2
Model: 1116556, 1116597
S/N: All serial numbers are affected

Afinion 2
Model: 1116679, 1116680, 1116770, 1116771
S/N: All serial numbers are affected

Alere Afinion AS100 Analyzer
Model: 1116049, 1116050
S/N: All serial numbers are affected

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

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

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

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

Vk_20200323_16

31.03.2020

Quality In Flow (QinFlow) Ltd.

AC power supply module
Model: QACPLUS1000
Lot: ACM00068, ACM00091, ACM00092

MD: Basic power supply

EN-1

Vk_20200317_17

25.03.2020 

(Updated 30.03.2020)

Chromsystems Instruments & Chemicals GmbH

3PLUS1 Multilevel Plasma Calibrator Set Neuroleptics 1 /EXTENDED
Model: 92028/XT
Lot: 2219
S/N: n/a
SW-Version: n/a

MassCheck Neuroleptics 1 /EXTENDED Plasma Control Level 1
Model: 0211/XT
Lot: 2219

MassCheck Neuroleptics 1 /EXTENDED Plasma Control Level II
Model: 0212/XT
Lot: 2219

IVD: Multiple antipsychotic therapeutic drug monitoring IVD, kit, liquid chromatography/mass spectrometry (LC/MS)

IVD: Multiple antipsychotic therapeutic drug monitoring IVD, kit, liquid chromatography/mass spectrometry (LC/MS)

IVD: Multiple antipsychotic therapeutic drug monitoring IVD, kit, liquid chromatography/mass spectrometry (LC/MS)

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

Vk_20200317_06

17.03.2020 

(Updated 30.03.2020)

Servona GmbH

Servona Silberkanüle
Model: 32836 - 32970

MD: Tenaculum, uterine

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

Vk_20200313_08

19.03.2020 

(Updated 30.03.2020)

Axis-Shield Diagnostics Limited

Alere NT-proBNP Control
Model: see FSN
Lot: see FSN

Alere NT-pro BNP Calibrator
Model: see FSN
Lot: see FSN

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

IVD: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

DE-1
FR-1
EN-1

Vk_20200313_06

30.03.2020

PETER BREHM GmbH

Screw M6 short
Model: 60901-04
Lot: All

Allen Key SW 5 Ball Head
Model: 97021-55-1
Lot: All

Screw M6 long
Model: 60901-07
Lot: All

MD: Prostheses, Joint, Hip, Femoral Component

MD: Allen Key

MD: Prostheses, Joint, Hip, Femoral Component

DE-1
EN-1

Vk_20200221_07

25.03.2020

Philips Medical Systems

HeartStart MRx Defibrillator/ Monitor
Model: 861288, 861289, 861464, 861465, 861481, 861482, 861483, 861484, 861491, 860396, 860397, 860398

MD: Rechargeable professional automated external defibrillator

DE-1-Distributoren
DE-1-Endkunden
FR-1-Clients finaux
IT-1-Clienti finali
EN-1-Distributors
EN-1-End users

Vk_20200323_18

25.03.2020

Embla Systems

Remlogic
Model: 026259

MD: Sleep disorder interpretive software

DE-1
FR-1
EN-1

Vk_20200316_05

24.03.2020

Philips Medical Systems

TRx4841A 1.4 GHz IntelliVue Tele TRX
Model: See FSN

TRx4851A 2.4 GHz IntelliVue Tele TRX
Model: See FSN

MD: Monitor, physiological, patient (with arrhythmia detection or alarm)

MD: Monitor, physiological, patient (with arrhythmia detection or alarm)

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

Vk_20200323_04

24.03.2020

Waldemar Link GmbH & Co. KG

Endo-Model Knee Fusion Nail, Femoral, left, Size 1
Model: 15-8431/21;15-8431/21
Lot: 1937212
SW-Version: N/A

MD: Knee arthrodesis prosthesis

DE-1
EN-1

Vk_20200317_03

24.03.2020 

(Updated 24.03.2020)

Dedienne Santé

Symbol Cup
Model: 3700502202496, 3700502202533, 3700502202540; 3700502203226, 3700502203233, 3700502203240, 3700502203264, 3700502203271, 3700502203288, 3700502203295, 3700502203301
Lot: see FSN

MD: Acetabular shell

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

Vk_20200303_06

19.03.2020 

(Updated 23.03.2020)

Siemens Healthcare Diagnostics Products GmbH

Dade Ci-Trol 1
Model: 291070; SMN 10445601
Lot: 564805, 564805A, 564810, 564810A

IVD: Multiple coagulation factor IVD, control

DE-1
FR-1
EN-1

Vk_20200316_14

12.11.2019 

(Updated 23.03.2020)

TORNIER SAS

Aequalis Ascend Flex Shoulder System
Model: see FSN

MD: Total reverse shoulder prosthesis

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

Vk_20191107_21

11.03.2020 

(Updated 21.03.2020)

Sysmex Corporation

UF-4000
SW-Version: see FSN

UF-5000
SW-Version: see FSN

IVD: INSTRUMENTS , CONSUMABLES, SPARE PARTS, SOFTWARE, SERVICE

IVD: INSTRUMENTS , CONSUMABLES, SPARE PARTS, SOFTWARE, SERVICE

DE-1
EN-1

Vk_20200304_05

04.03.2020 

(Updated 21.03.2020)

Biocartis NV

Idylla EGFR Mutation Test
Model: A0060/6
Lot: N/A
SW-Version: N/A

IVD: Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

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

Vk_20200225_16

20.03.2020

C-RAD Positioning AB

c-Rad c4D software
Lot: all

MD: Radiation therapy software

DE-1
IT-1
EN-1

Vk_20200302_15

20.03.2020

MAG & more

PowerMAG
S/N: SN 471810010 (Apollo) SN 091900361 (HANS Coil)

MD: Stimulator

DE-1
EN-1

Vk_20200203_24

28.01.2020 

(Updated 20.03.2020)

Roche Diagnostics GmbH

Elecsys CA 19-9
Model: 07027028190
Lot: 416245

IVD: Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

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

Vk_20200124_20

19.03.2020

Biomet Orthopaedics, LLC

StageOne Hip Cement Spacer Mold,
Model: see FSN
Lot: all lots exp. prior to 28. Feb.2030
SW-Version: N/A

MD: Orthopaedic cement spacer mould

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

Vk_20200313_09

16.03.2020

GGT Holding BV

Telefunken / HeartReset
Model: 8718481270XX-8718481275XX
Lot: 1629015177-1839859023

MD: AED, automated external defibrillator

DE-1

Vk_20200311_20

13.03.2020

WRP Asia Pacific

Dermagrip Ellbogen-Handschuh
Model: D3985-15
Lot: 60301149

MD: Hevea-latex surgical glove, non-powdered

DE-1

Vk_20200313_11

10.03.2020 

(Updated 12.03.2020)

Siemens Healthcare Diagnostics Products GmbH

N Latex CDT
Model: OPCS03, SMN 10445996, OPCS05, SMN 10445997
Lot: 49729, 49822, 49849, 49985, 50084

IVD: Transferrin kit

DE-1
FR-1
EN-1

Vk_20200305_12

12.03.2020

Siemens Healthcare Diagnostics Inc.

Atellica CH 930 Analyzer
Model: 11067000
Lot: N/A
S/N: N/A
SW-Version: V1.21.0 and prior

IVD: Chemiluminescent immunoassay analyser IVD, automated

DE-1
EN-1

Vk_20200303_05

11.03.2020

Mint Medical GmbH

mint Lesion
SW-Version: 3.5 - 3.6 with active LI-RADS Modul

MD: Picture archiving and communication systems (PACS), radiology

DE-1

Vk_20200306_10

09.03.2020 

(Updated 11.03.2020)

Mölnlycke Health Care AB

Optical Trocar 12mm/100mm
Model: 319428-00

Universal Trocar Cannula 12mm / 100mm
Model: 2319467-00

MD: Endotherapy trocar, single-use

MD: Endotherapy trocar, single-use

DE-1_customer
DE-1_distributor

Vk_20200227_07

10.03.2020

Boston Scientific Corporation

Sensor
Model: See FSN
Lot: See FSN

MD: Gastro-urological guidewire, single-use

DE-1
FR-1
EN-1

Vk_20200309_10

10.03.2020

WITTENSTEIN intens GmbH

FITBONE Receiver
Model: 60001780

AIMD: Long bone distraction rod receiver

DE-1
EN-1

Vk_20200228_04

06.03.2020

Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)

Olympic Brainz Monitor
Model: OBM00002

MD: Electroencephalograph

DE-1
FR-1
EN-1

Vk_20200303_01

06.03.2020

Cryopal

CONTAINERS , CRYO BIOLOGICAL STORAGE

MD: Cryobiological storage container

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

Vk_20200213_10

06.03.2020

Cryopal

Arpege
Model: ARPEGE 55 and ARPEGE 75
Lot: ARPEGE55N-L-101, ARPEGE55N-L-102, ARPEGE55N-L-103, ARPEGE75N-L-101, ARPEGE75N-L-102, ARPEGE75N-L-103

MD: Cryobiological storage container

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

Vk_20200213_09

05.03.2020

Advanced Bionics AG

HiRes Ultra / HiRes Ultra 3D
Model: CI-1600-04, CI-1600-05, CI-1601-04, CI-1601-05

AIMD: Cochlear implant system electrode array assembly

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

Vk_20200218_02

05.03.2020

Medtron AG

MR-Set ELS 65ml
Model: REF 317602-000 (Set); REF 316065-000 (Syringe)
Lot: see FSN

MD: Double-Axis Electrogoniometers

DE-1
FR-1
IT-1

Vk_20200213_16

04.03.2020

Zimmer Biomet GmbH

Anatomical Shoulder Trial Humeral PE-Insert
Model: 01.04239.730
Lot: 4502624503, 4503070153

MD: Joint prosthesis implantation kit, reusable

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

Vk_20200228_07

04.03.2020

Beckman Coulter Ireland, Inc.

iChem VELOCITY Urine Chemistry Strips
Model: 800-7204
Lot: 7204285M , 7204286A
S/N: Not applicable
SW-Version: Not applicable

IVD: Urine rapid test device, multiple-constituent

DE-1
FR-1
EN-1

Vk_20200227_15