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HbA1c Test Cassette

by Hangzhou Alltest Biotech.Co., Ltd. China EUDAMED

Ref FI-HBA-402 EMDN W0102160102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-FI-HBA-402HX Basic UDI-DIDate12 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
HbA1c Test Cassette
Model / Reference
FI-HBA-402
Primary DI / UDI-DI
D-FI-HBA-402HX
Basic UDI-DI
B-FI-HBA-402HX
EMDN Code
W0102160102 Glycosylated/glycated haemoglobin (ic) rt & poc
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Hangzhou Alltest Biotech.Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
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
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-FI-HBA-402HX|B-FI-HBA-402HX 61 fields · synced 24 Oct 2026