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HbA1c Assay Kit (HPLC)

by Shanghai Medconn Biotechnology Co., Ltd. China EUDAMED

Model HC230T01, HC237T03, HC237T02, HC234T10 EMDN W0103010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06954418503636 Basic UDI-DIDate17 Nov 2023RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
HbA1c Assay Kit (HPLC)
Model / Reference
HC230T01, HC237T03, HC237T02, HC234T10
Primary DI / UDI-DI
06954418503636, 06954418512355, 06954418503834, 06954418503667
Basic UDI-DI
B-06954418503636, B-06954418512355, B-06954418503834, B-06954418503667
EMDN Code
W0103010199 Reagents for (automated) haematology analyzer - other
Device Class
Class IVD General
Market of Registration
Denmark
Greece
Croatia

Manufacturer details

EUDAMED SRN
CN-MF-000038615
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shanghai Medconn Biotechnology Co., Ltd.

See all devices from Shanghai Medconn Biotechnology Co., Ltd. →

Properties & raw data

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

Sources (4)

  • EUDAMED c0c8213f-cc2f-4837-bc49-0e78bb9aa9e5 61 fields · synced 22 Oct 2026
  • EUDAMED 06954418512355|B-06954418512355 61 fields · synced 17 May 2026
  • EUDAMED 06954418503834|B-06954418503834 61 fields · synced 18 May 2026
  • EUDAMED 06954418503667|B-06954418503667 61 fields · synced 18 May 2026