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CERA-CHEK™ 3 in 1 GHL Hemoglobin Control Solution

by GC MEDIS Corp. South Korea EUDAMED

Ref M400C11Model M 400 EMDN W0103010504

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08800065170203 Basic UDI-DIDate26 Oct 2022RegisteredStatusActive

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  • Withdrawn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
Hemoglobin Control Solution
Model / Reference
M 400, M400C11
Primary DI / UDI-DI
08800065170203
Basic UDI-DI
B-08800065170203
EMDN Code
W0103010504 Haemoglobin controls
Device Class
Class IVD Annex II List B
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
KR-MF-000012638
Authorised representative
Obelis s.a. BE-AR-000000106

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See all devices from GC MEDIS Corp. →

Properties & raw data

Show properties, registry sources and raw records
  • Self Testing
  • Near-Patient Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED defb4f1a-2ae5-465b-abbf-e0875e890541 61 fields · synced 22 Oct 2026