Unknown / Not in EUDAMED

Snapshot 2026-10-18 · Link to EUDAMED

Fixed Bearing Tibial Insert

UDI-DI 10603295250463Basic UDI-DI 0603295a003158J

Class III · MDR · DePuy Ireland UC

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Identification

Model: SIGMA P.F.C. SIGMA Fixed Bearing Tibial Insert
EMDN: P090903020202
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 776531

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-07-15 · Expiry 2029-09-11

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

DePuy Ireland UC

SRN IE-MF-000007377

IE · Ringaskiddy, Co. Cork

manufacturer

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Showing 12 of 370 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/fixed-bearing-tibial-insert-0463 · UDI page: /udi/10603295250463

All devices from DePuy Ireland UC

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