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LVOne

by Pockit diagnostics Ltd

Ref PDL-EUK

Active European Union

CE IVDR

Valid until

21 May 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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/IVDR Number50700022781LV1K7 Basic UDI-DI 05070002278122UDI-DIDate4 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 793171 Active

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    22 May 2026
    Expires
    21 May 2031

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
PDL-EUK
Primary DI / UDI-DI
05070002278122
Basic UDI-DI
50700022781LV1K7
Direct Marketing DI
05070002278122
EMDN Code
W01021699 Rapid tests & point of care - immunochemistry - other
Device Class
Class C
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
UK-MF-000044740
Authorised representative
QbD RepS BV BE-AR-000000040

Properties

  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing
  • New Device

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No