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Trium

by X.nov Medical Technology 47 variants

Ref PG04-0214Model BICOMPARTMENTAL PRIMARY IMPLANT MOBILE BEARING TIBIAL INSERTS

Active European Union

CE MDR

Valid until

2 Jan 2028

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 Number3700535100034PW Basic UDI-DI 03700535129982UDI-DIDate4 Nov 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 763100 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    21 Jul 2025
    Expires
    2 Jan 2028
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
BICOMPARTMENTAL PRIMARY IMPLANT MOBILE BEARING TIBIAL INSERTS, PG04-0214
Primary DI / UDI-DI
03700535129982
Basic UDI-DI
3700535100034PW
EMDN Code
P090903020201 Bicompartmental primary implant mobile bearing tibial inserts
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