Skip to content

CERA-STAT™ HbA1c Test Kit

by GC MEDIS Corp. South Korea EUDAMED

Ref CS400S10Model CS 4000

EMDN W0101060107

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08800065144402 Basic UDI-DIDate22 Jul 2024RegisteredStatusActive

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

Model / Reference
CS 4000, CS400S10
Primary DI / UDI-DI
08800065144402
Basic UDI-DI
B-08800065144402
EMDN Code
W0101060107 Hba1c test strips
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
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED ae615a32-59a5-4177-b0b6-26f21f087e92 61 fields · synced 22 Oct 2026