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Tête Céramique Composite – diamètre 40 mm Col Moyen 0 mm
EUDAMEDClass III (EU MDR)
Ref 13-03-40-02Model tête fémorale en céramique composite - DMR 13-03-00-00 (B??)
Identity
- Trade Name
- Tête Céramique Composite – diamètre 40 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??) EUDAMED13-03-40-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EPRS13034002B0 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
Category: Ceramic femoral head prosthesis
Tête Céramique Composite – diamètre 40 mm Col Moyen 0 mm by Protheos Industrie — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ceramic femoral head prosthesis.
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- BIOLOX® delta Modular Ceramic Head — Biomet Uk Ltd · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- SYNERGY — Smith & Nephew, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
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 be7e8fdc-ef1c-4320-bf33-9aa6e72ff0ea 61 fields · synced Jun 19, 2026