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SVL - Insert, 2R-12

by BEZNOSKA, s.r.o. EUDAMED

Active European Union

Ref 358053

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859260202001EW Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2026-MDR/QS-018 Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    5 Mar 2026
    Expires
    5 Mar 2031
  • 2026-MDR/TD-018 Issued

    Technical documentation EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    5 Mar 2026
    Expires
    5 Mar 2031

Specification

EUDAMED

Device Name
Knee Replacement Systems and Ancillary Elements for Knee Replacement
Model / Reference
358053
Primary DI / UDI-DI
08592602125837
Basic UDI-DI
859260202001EW
EMDN Code
P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
Device Class
Class III
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000000543

Other devices from BEZNOSKA, s.r.o.

See all devices from BEZNOSKA, s.r.o. →

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