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NT-proBNP Immunofluorescence Assay

by Guangzhou KOFA Biotechnology Co., Ltd. 6 variants

Ref GQ-BN03-B

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-06975599465148 Basic UDI-DIDate14 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
GQ-BN03-B
Primary DI / UDI-DI
06975599465148
Basic UDI-DI
B-06975599465148
EMDN Code
W01021301 Bnp / probnp (including other natriuric peptides)
Device Class
Class IVD General
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.

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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