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Covision

by Covision Medical Technologies Ltd. 368 variants

Ref 01.3653NModel ST.LEGER NEO C/R TIBIAL INSERT (XL) 65mm 11mm

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-05051659061633 Basic UDI-DI 05051659061633UDI-DIDate13 Jun 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
ST.LEGER NEO C/R TIBIAL INSERT (XL) 65mm 11mm
Model / Reference
ST.LEGER NEO C/R TIBIAL INSERT (XL) 65mm 11mm, 01.3653N
Primary DI / UDI-DI
05051659061633
Basic UDI-DI
B-05051659061633
EMDN Code
P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
Device Class
Class III
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
GB-MF-000025081
Authorised representative
Covision Medical Technologies (Ireland) Limited IE-AR-000031129

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Properties

  • Sterile
  • Implantable

Other properties (9)

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