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Hemoglobin A1c testing kit (latex immunoturbidimetric method)

by URIT Medical Electronic Co., Ltd. China EUDAMED

Ref "REF: U84182015M, U84182045M, U84189060M, U84185015M, U84120060M"

EMDN W0102060109

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-6-35AD Basic UDI-DIDate21 May 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 22 Oct 2026

Device Name
Hemoglobin A1c testing kit (latex immunoturbidimetric method)
Model / Reference
"REF: U84182015M, U84182045M, U84189060M, U84185015M, U84120060M"
Primary DI / UDI-DI
D-6-35AD
Basic UDI-DI
B-6-35AD
EMDN Code
W0102060109 Glycosylated/glycated haemoglobin (ic)
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000011840
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from URIT Medical Electronic Co., Ltd.

See all devices from URIT Medical Electronic Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 0a21c6c2-892b-4b05-a8b3-de8210ab06fb-1 61 fields · synced 22 Oct 2026