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Tkaps

by X.nov Medical Technology 57 variants

Ref PG03-0600Model Bicompartimental primary implant cemented mobile bearing tibial plates

Active European Union

CE MDR

Valid until

15 Oct 2029

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 Number3700535100061PZ Basic UDI-DI 03700535104293UDI-DIDate27 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 785395 Active

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    16 Oct 2025
    Expires
    15 Oct 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Bicompartimental primary implant cemented mobile bearing tibial plates, PG03-0600
Primary DI / UDI-DI
03700535104293
Basic UDI-DI
3700535100061PZ
EMDN Code
P090903020101 Bicompartmental primary implant cemented mobile bearing 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

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