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BioHermes Glycohemoglobin Reagent Kit (HPLC, Variant Mode) BH-L02

by Wuxi Biohermes Bio & Medical Technology Co., Ltd. 4 variants

Ref HP-L222Model BH-L02

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-06935784430320 Basic UDI-DI 06935784430320UDI-DIDate10 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06935784430320 UDI-DI Date5 Jan 2022ListedStatusListed 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  • Withdrawn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 Glycohemoglobin Reagent Kit (HPLC, Variant Mode)
Generic Name
Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
Model / Ref / Catalog
BH-L02, HP-L222
Primary DI / UDI-DI
06935784430320
Basic UDI-DI
B-06935784430320
EMDN Code
W0101060107 Hba1c test strips
GMDN Term
Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
Device Class
Class IVD General
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

  • Reagent
  • Professional Testing
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: 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