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Wielofunkcyjny Glukometr Szpitalny VivaChek Pro

by VivaChek Biotech (Hangzhou) Co., Ltd.

Ref VGM9802-725Model VGM9802

Active European Union

CE IVDR

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/IVDR Number697022176VGM9802000226 Basic UDI-DI 06970221768703UDI-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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
VivaChek Pro Hospital Multi-function Meter
Model / Reference
VGM9802, VGM9802-725
Primary DI / UDI-DI
06970221768703
Basic UDI-DI
697022176VGM9802000226
EMDN Code
W020106019099 Various diabetes monitoring instruments - other
Device Class
Class A
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

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No