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GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

by GeneProof a.s. 2 variants

Ref HCVD/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 linked in EUDAMED

A group certificate may exist

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-08594161956891 Basic UDI-DI 08594161956891UDI-DIDate27 Apr 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
HCVD/ISEX/100
Primary DI / UDI-DI
08594161956891
Basic UDI-DI
B-08594161956891
EMDN Code
W0105020307 Hepatitis c virus - na reagents
Device Class
Class IVD Annex II List A
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

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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