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PNAClamp™ KRAS Mutation Detection Kit (Ver.4)

by Hlb Panagene

Ref PNAC-1006Model PNAClamp™ KRAS Mutation Detection Kit (Ver.4)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08809378688948 Basic UDI-DI 08809378688948UDI-DIDate9 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  • Withdrawn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

Device Name
PNAClamp™ KRAS Mutation Detection Kit (Ver.4)
Model / Reference
PNAClamp™ KRAS Mutation Detection Kit (Ver.4), PNAC-1006
Primary DI / UDI-DI
08809378688948
Basic UDI-DI
B-08809378688948
EMDN Code
W01060202 K-ras
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000042004
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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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