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Total-P1NP CLIA

by Guangzhou KOFA Biotechnology Co., Ltd. 8 variants

Ref GPP88K2N

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06942609216281 Basic UDI-DI 06942609216281UDI-DIDate23 Jul 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  • Withdrawn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

Model / Reference
GPP88K2N
Primary DI / UDI-DI
06942609216281
Basic UDI-DI
B-06942609216281
EMDN Code
W0102060317 Procollagen type i n terminal propeptide
Device Class
Class IVD General
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000045346
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Guangzhou KOFA Biotechnology Co., Ltd.

See all devices from Guangzhou KOFA Biotechnology Co., Ltd. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No