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Kaps

by X.nov Medical Technology 59 variants

Ref PG01-3701Model Unicompartimental knee protheses femoral components (unicondylar), cemented

Active European Union

CE MDR

Valid until

26 May 2030

CE MDR 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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3700535100051PW Basic UDI-DI 03700535103326UDI-DIDate27 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 777387 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    21 Jul 2025
    Expires
    26 May 2030
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Unicompartimental knee protheses femoral components (unicondylar), cemented, PG01-3701
Primary DI / UDI-DI
03700535103326
Basic UDI-DI
3700535100051PW
EMDN Code
P090904020104 Fixed uncemented unicompartmental primary implant tibial plates
Device Class
Class III
EU market of registration
France

Manufacturer details

EUDAMED SRN
CH-MF-000018319
Authorised representative
X.NOV FR-AR-000007682

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Properties

  • Sterile
  • Implantable

Other properties (11)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No