Skip to content

U2 Total Knee System

by United Orthopedic Corporation Taiwan EUDAMED

Ref 9403-6060

EMDN L090402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471987216TD-Ir-003F4 Basic UDI-DIDate18 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
United Hip and Knee Non-sterile Reusable Instruments
Model / Reference
9403-6060
Primary DI / UDI-DI
04719872157175
Basic UDI-DI
471987216TD-Ir-003F4
Direct Marketing DI
04719872157175
EMDN Code
L090402 Orthopaedic surgery scalpels, reusable
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
TW-MF-000009523
Authorised representative
mdi Europa GmbH DE-AR-000006218

From the manufacturer

Manufacturer's product page: Total Knee Replacement

Other devices from United Orthopedic Corporation

See all devices from United Orthopedic Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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

Sources (1)

  • EUDAMED 74209b2f-bb8a-4462-a8a9-a48e1369c2d0 61 fields · synced 22 Oct 2026