Skip to content

Glycated Hemoglobin Analyzer

by B&E Bio-Technology Co., Ltd. China EUDAMED

Ref G80Model G20, G21, G60, G80

EMDN W0201060101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697233785GHgbA010ME Basic UDI-DIDate22 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Glycated Hemoglobin Analyzer
Model / Reference
G20, G21, G60, G80
Primary DI / UDI-DI
06972337858088
Basic UDI-DI
697233785GHgbA010ME
EMDN Code
W0201060101 Glycosilated hemoglobin devices
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000023256
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from B&E Bio-Technology Co., Ltd.

See all devices from B&E Bio-Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 45fa9ecb-e0d6-47cc-a374-6224da98212e 61 fields · synced 22 Oct 2026