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K-MONO INSERT UHMWPE RM/LL 2x8

by Gruppo Bioimpianti SRL EUDAMED

Active European Union

Ref 120704202

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08033466130334 Basic UDI-DIDate1 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

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.

Specification

EUDAMED

Device Name
K-Mono
Model / Reference
120704202
Primary DI / UDI-DI
08033466130334
Basic UDI-DI
B-08033466130334
EMDN Code
P090904020202 Unicompartmental knee prostheses tibial inserts, fixed
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000038206

Other devices from Gruppo Bioimpianti SRL

See all devices from Gruppo Bioimpianti SRL →

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