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CERA-STAT™ 4000 Analyzer

by GC MEDIS Corp. South Korea EUDAMED

Ref CS400M10Model CS 4000 EMDN W0201060101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number88000651HAAHM000C8 Basic UDI-DIDate22 Jul 2024RegisteredStatusActive
European UnionCE/IVDR Number88000651HAAHM000C8 Basic UDI-DIDate22 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CS400M10, CS 4000
Primary DI / UDI-DI
08800065166008
Basic UDI-DI
88000651HAAHM000C8, B-08800065166008
EMDN Code
W0201060101 Glycosilated hemoglobin devices
Device Class
Class A
Class IVD General
Market of Registration
Belgium

Manufacturer details

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

Other devices from GC MEDIS Corp.

See all devices from GC MEDIS Corp. →

Properties & raw data

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

Sources (2)

  • EUDAMED a28ea1af-b45b-423c-b5ae-5268ea4ab7d8 61 fields · synced 22 Oct 2026
  • EUDAMED 08800065166008|B-08800065166008 61 fields · synced 19 May 2026