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GeneProof BK/JC Virus (BK/JC) PCR Kit

by GeneProof a.s. 2 variants

Ref BKJC/ISEX/100

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-08594161952572 Basic UDI-DI 08594161952572UDI-DIDate26 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  • Withdrawn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

Model / Reference
BKJC/ISEX/100
Primary DI / UDI-DI
08594161952572
Basic UDI-DI
B-08594161952572
EMDN Code
W0105040522, W0105040523
Device Class
Class IVD General
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000002370

From the manufacturer

Manufacturer's product page: Solutions

Other devices from GeneProof a.s.

See all devices from GeneProof a.s. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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