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Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Cemented Fixed Bearing Tibial Tray (CoCr Alloy)

UDI-DI 10603295064909Basic UDI-DI 0603295a005699K

Class III · MDR · DePuy Ireland UC

Identification
Model
P.F.C. SIGMA Cemented Fixed Bearing Tibial Tray (CoCr Alloy)
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

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/cemented-fixed-bearing-tibial-tray-cocr-alloy-4909 · UDI page: /udi/10603295064909

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