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CERA-CHEK™ Hb Plus Hemoglobin Measuring System

by GC MEDIS Corp. South Korea EUDAMED

Ref B400M10Model H 400 EMDN W0201069099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08800065152018 Basic UDI-DIDate11 Jun 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  • Withdrawn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
H 400, B400M10
Primary DI / UDI-DI
08800065152018
Basic UDI-DI
B-08800065152018
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class IVD devices for self-testing
Market of Registration
Romania

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
  • Self Testing
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED d0aa68fa-d115-4df6-9141-b1f5454334d2 61 fields · synced 22 Oct 2026