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BioHermes GluCoA1c Blood Glucose Test Strips GLU-A1C S06

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

Ref GLU-S32Model GLU-A1C S06

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-06935784420055 Basic UDI-DI Date8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06935784420055 UDI-DI Date25 May 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
BioHermes GluCoA1c Blood Glucose Test Strips
Generic Name
Glucose IVD, kit, electrometry
Model / Ref / Catalog
GLU-A1C S06, GLU-S32
Primary DI / UDI-DI
06935784420055, 16935784420052
Basic UDI-DI
B-06935784420055, B-16935784420052
EMDN Code
W0101060101 Glucose test strips
GMDN Term
Glucose IVD, kit, electrometry
Device Class
Class IVD devices for self-testing
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

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

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

Properties

  • Single Use
  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing NoEUDAMEDYesEUDAMED
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (14)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No