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Glycohemoglobin Analyzer

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

Ref A1C-M22Model A1C EZ 2.0 BT

EMDN W0201060101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06935784410018 Basic UDI-DIDate29 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Glycohemoglobin Analyzer
Model / Reference
A1C EZ 2.0 BT, A1C-M22
Primary DI / UDI-DI
06935784410018, 16935784410015
Basic UDI-DI
B-06935784410018, B-16935784410015
EMDN Code
W0201060101 Glycosilated hemoglobin devices
Device Class
Class IVD devices for self-testing
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 & raw data

Show properties, registry sources and raw records
  • Self Testing
  • Near-Patient Testing
  • Professional Testing NoEUDAMEDYesEUDAMED
  • Surgical Instrument
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Companion Diagnostics: No

Sources (2)

  • EUDAMED ea38490e-48f0-4b75-b21b-50d2e9523a65 61 fields · synced 24 Oct 2026
  • EUDAMED 16935784410015|B-16935784410015 61 fields · synced 9 Oct 2026