Skip to content

Glycated Hemoglobin (HbA1c) Assay Kit

by Shanghai Medconn Biotechnology Co., Ltd. China EUDAMED

Model HC207T05 EMDN W0103010199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06954418503612 Basic UDI-DIDate16 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  • Withdrawn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
Glycated Hemoglobin (HbA1c) Assay Kit
Model / Reference
HC207T05
Primary DI / UDI-DI
06954418503612
Basic UDI-DI
B-06954418503612
EMDN Code
W0103010199 Reagents for (automated) haematology analyzer - other
Device Class
Class IVD General
Market of Registration
Germany

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
  • Companion Diagnostics
Other properties (6)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED d4897202-ba63-4536-936b-23079f983db0 61 fields · synced 22 Oct 2026