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Cotyle XLfit non cimenté diam. 32/48 mm
EUDAMEDClass III (EU MDR)
Ref 15-03-32-48Model cotyle XLFIT
Identity
- Trade Name
- Cotyle XLfit non cimenté diam. 32/48 mm EUDAMED
- Device Name
- XLFIT acetabular cup EUDAMED
- Model / Reference
- cotyle XLFIT EUDAMED15-03-32-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EPRS15033248A0 EUDAMED
- Basic UDI-DI
- B-EPRS15033248A0 EUDAMED
- EMDN Code
- P0908030601 PRE-ASSEMBLED ACETABULAR COMPONENTS WITH CERAMIC INSERT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cotyle XLfit non cimenté diam. 32/48 mm by Protheos Industrie — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-EPRS15033248A0 | Class III | Active |
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Manufacturer
- Manufacturer
- Protheos Industrie
- EUDAMED SRN
- FR-MF-000000150
Sources (1)
- EUDAMED 6b4934da-d6fb-4e9a-ad20-d7aa03f998e9 61 fields · synced Jun 19, 2026