Skip to content

Kaps

by X.nov Medical Technology 86 variants

Ref PG01-0003Model 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 Number3700535100044PZ Basic UDI-DI 03700535102039UDI-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  • Withdrawn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, PG01-0003
Primary DI / UDI-DI
03700535102039
Basic UDI-DI
3700535100044PZ
EMDN Code
P0909040101 Unicompartmental knee prostheses femoral components (unicondylar), cemented
Device Class
Class III
EU market of registration
France

Manufacturer details

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

Other devices from X.nov Medical Technology

See all devices from X.nov Medical Technology →

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