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Glycated Hemoglobin A1c Test Kit (Immunofluorescence)

by Guangdong Wesail Biotech Co., Ltd. China EUDAMED

Ref BA0040Model 20 tests/kit EMDN W0102160102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973841000888 Basic UDI-DIDate25 May 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  • Withdrawn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 23 Oct 2026

Model / Reference
20 tests/kit, BA0040
Primary DI / UDI-DI
06973841000888
Basic UDI-DI
B-06973841000888
EMDN Code
W0102160102 Glycosylated/glycated haemoglobin (ic) rt & poc
Device Class
Class IVD General
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000008828
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Guangdong Wesail Biotech Co., Ltd.

See all devices from Guangdong Wesail Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 9fe9f296-526a-45d1-8ec7-4a11a7d88df6 61 fields · synced 23 Oct 2026