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CERA-STAT™ HbA1c Control Solution

by GC MEDIS Corp. South Korea EUDAMED

Ref CS400C10Model CS 4000 EMDN W0101050205

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08800065178001 Basic UDI-DIDate22 Jul 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
CS 4000, CS400C10
Primary DI / UDI-DI
08800065178001
Basic UDI-DI
B-08800065178001
EMDN Code
W0101050205 Diabetes controls
Device Class
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
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED a21b5cee-fab0-48b6-9083-8b0f51c2e4df 61 fields · synced 22 Oct 2026