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Blood Glucose / Blood Ketone / Uric Acid/ Hemoglobin Multi-Monitoring system

by Wuxi Biohermes Bio & Medical Technology Co., Ltd. 10 variants

Ref GUK-M31Model GUK 3.0

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CNMF000014455-GUK-M318D Basic UDI-DI D-CNMF000014455-GUK-M318DUDI-DIDate5 Jun 2026RegisteredStatusActive

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  • Withdrawn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
Blood Glucose / Blood Ketone / Uric Acid/ Hemoglobin Multi-Monitoring system
Model / Reference
GUK 3.0, GUK-M31
Primary DI / UDI-DI
D-CNMF000014455-GUK-M318D
Basic UDI-DI
B-CNMF000014455-GUK-M318D
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000014455
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Wuxi Biohermes Bio & Medical Technology Co., Ltd.

See all devices from Wuxi Biohermes Bio & Medical Technology Co., Ltd. →

Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No