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Tige THEOS HAP non cimentée standard Taille 11
EUDAMEDClass III (EU MDR)
Ref 11-03-11Model tige THEOS HAPModel tige THEOS HAP - DMR 11-03-00 (B??)
Identity
- Trade Name
- Tige THEOS HAP non cimentée standard Taille 11 EUDAMED
- Device Name
- THEOS HAP femoral stem EUDAMED
- Model / Reference
- tige THEOS HAP EUDAMED11-03-11 EUDAMEDtige THEOS HAP - DMR 11-03-00 (B??) EUDAMED
Identifiers
- Primary DI / UDI-DI
- EPRS110311A0 EUDAMEDEPRS110311B0 EUDAMED
- Basic UDI-DI
- B-EPRS110311A0 EUDAMED++EPRS110300BM2 EUDAMED
- EMDN Code
- P090804010201 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT 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
Tige THEOS HAP non cimentée standard Taille 11 by Protheos Industrie — Class III — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-EPRS110311A0 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-EPRS110311A0 | Class III | Active |
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Manufacturer
- Manufacturer
- Protheos Industrie
- EUDAMED SRN
- FR-MF-000000150
Sources (2)
- EUDAMED ab3b4d3d-af95-4fba-865a-c3a7a26c2523 61 fields · synced Jul 29, 2026
- EUDAMED f742fad0-647a-4125-93f3-79b0070d5f0d 61 fields · synced May 17, 2026