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Tête Céramique Composite – diamètre 44 mm Col Moyen 0 mm
EUDAMEDClass III (EU MDR)
Ref 13-03-44-02Model tête fémorale en céramique composite - DMR 13-03-00-00 (B??)
Identity
- Trade Name
- Tête Céramique Composite – diamètre 44 mm Col Moyen 0 mm EUDAMED
- Device Name
- ceramic femoral head EUDAMED
- Model / Reference
- tête fémorale en céramique composite - DMR 13-03-00-00 (B??) EUDAMED13-03-44-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EPRS13034402B0 EUDAMED
- Basic UDI-DI
- ++EPRS13030000BSW EUDAMED
- EMDN Code
- P090804050201 CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Tête Céramique Composite – diamètre 44 mm Col Moyen 0 mm by Protheos Industrie — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EPRS13030000BSW | Class III | Active |
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Manufacturer
- Manufacturer
- Protheos Industrie
- EUDAMED SRN
- FR-MF-000000150
Sources (1)
- EUDAMED 4e8bdd8c-3710-49f5-b235-bc6d9f21eeca 61 fields · synced Oct 6, 2026