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Innodx Afp Cmia

by Xiamen Innodx Biotech Co., Ltd.

Ref KR-AFP-01100C

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-KR-AFP-01100CPX Basic UDI-DI D-KR-AFP-01100CPXUDI-DIDate20 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Kr-Afp-01100C
Model / Reference
KR-AFP-01100C
Primary DI / UDI-DI
D-KR-AFP-01100CPX
Basic UDI-DI
B-KR-AFP-01100CPX
EMDN Code
W0102039001 Alphafetoprotein
Device Class
Class IVD General
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000041071
Authorised representative
QbD RepS BV BE-AR-000000040

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No