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Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry)

by Genrui Biotech Inc. China EUDAMED

Ref 32080008Model 2*25 tests EMDN W0102060109

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number69503348PA041HX Basic UDI-DIDate28 Apr 2026RegisteredStatusActive
European UnionCE/IVDR Number69503348PA041HX Basic UDI-DIDate28 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
32080008, 2*25 tests
Primary DI / UDI-DI
06950334802174, D-PA00014X
Basic UDI-DI
69503348PA041HX, B-PA00014X
EMDN Code
W0102060109 Glycosylated/glycated haemoglobin (ic)
Device Class
Class C
Class IVD General
Market of Registration
Bulgaria
France

Manufacturer details

EUDAMED SRN
CN-MF-000017351
Authorised representative
Lotus NL B.V. NL-AR-000000121

From the manufacturer

Manufacturer's product page: LungeKlar® Seven Lung Cancer-associated Autoantibodies Detection Kit (CLIA)

Other devices from Genrui Biotech Inc.

See all devices from Genrui Biotech Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 3e6d7d4d-f5ca-4620-aa28-b786de9fa0fd 61 fields · synced 22 Oct 2026
  • EUDAMED D-PA00014X|B-PA00014X 61 fields · synced 19 May 2026