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Płyn kontrolny do pomiaru stężenia glukozy we krwi VivaChek Fad

by VivaChek Biotech (Hangzhou) Co., Ltd.

Ref VGC02-031Model VGC02

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970221768697 Basic UDI-DI 06970221768697UDI-DIDate17 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
VivaChek Fad Blood Glucose Control Solution
Model / Reference
VGC02, VGC02-031
Primary DI / UDI-DI
06970221768697
Basic UDI-DI
B-06970221768697
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class IVD General
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000012160
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Vivachek Biotech (Hangzhou) Co., Ltd.

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No