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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

Rotating Platform Tibial Inserts

UDI-DI 10603295240761Basic UDI-DI 0603295a003178N

Class III · MDR · DePuy Ireland UC

Identification
Model
P.F.C. SIGMA Rotating Platform Tibial Inserts
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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Canonical device page: /device/rotating-platform-tibial-inserts-0761 · UDI page: /udi/10603295240761

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