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Tige THEOS HAP non cimentée standard Taille 4
EUDAMEDClass III (EU MDR)
Ref 11-03-04Model tige THEOS HAP
Identity
- Trade Name
- Tige THEOS HAP non cimentée standard Taille 4 EUDAMED
- Device Name
- THEOS HAP femoral stem EUDAMED
- Model / Reference
- tige THEOS HAP EUDAMED11-03-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EPRS110304A0 EUDAMED
- Basic UDI-DI
- B-EPRS110304A0 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
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
Tige THEOS HAP non cimentée standard Taille 4 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-EPRS110304A0 | Class III | Active |
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Manufacturer
- Manufacturer
- Protheos Industrie
- EUDAMED SRN
- FR-MF-000000150
Sources (1)
- EUDAMED 4bc22a79-c480-49d6-9a6e-1182b91df48c 61 fields · synced Jun 18, 2026