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CERA-CHEK™ 3 in 1 GHL Hemoglobin Test Strip

by GC MEDIS Corp.

Ref M400S11Model M 400

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08800065140220 Basic UDI-DI 08800065140220UDI-DIDate9 Feb 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Hemoglobin Test Strip
Model / Reference
M 400, M400S11
Primary DI / UDI-DI
08800065140220
Basic UDI-DI
B-08800065140220
EMDN Code
W0103010201 Haemoglobin determinations (total hb)
Device Class
Class IVD Annex II List B
EU market of registration
Belgium

Manufacturer details

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

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Properties

  • Reagent
  • Self Testing
  • Near-Patient Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No