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Hemoglobin A1c Control

by Shanghai Medconn Biotechnology Co., Ltd. China EUDAMED

Ref NAModel HC235T01

EMDN W0103010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06954418512324 Basic UDI-DIDate17 Nov 2023RegisteredStatusActive

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 Control
Model / Reference
HC235T01, NA
Primary DI / UDI-DI
06954418512324
Basic UDI-DI
B-06954418512324
EMDN Code
W0103010199 Reagents for (automated) haematology analyzer - other
Device Class
Class IVD General
Market of Registration
Greece

Manufacturer details

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

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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 (1)

  • EUDAMED a33582c5-7582-45d9-ac7f-2228dfe6fee1 61 fields · synced 22 Oct 2026