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Tige THELIOS HAP non cimentée Taille 13 Standard
EUDAMEDClass III (EU MDR)
Ref 11-12-13Model tige THELIOS HAP
Identity
- Trade Name
- Tige THELIOS HAP non cimentée Taille 13 Standard EUDAMED
- Device Name
- THELIOS HAP collarless femoral stem EUDAMED
- Model / Reference
- tige THELIOS HAP EUDAMED11-12-13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EPRS111213A0 EUDAMED
- Basic UDI-DI
- B-EPRS111213A0 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 THELIOS HAP non cimentée Taille 13 Standard 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-EPRS111213A0 | Class III | Active |
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Manufacturer
- Manufacturer
- Protheos Industrie
- EUDAMED SRN
- FR-MF-000000150
Sources (1)
- EUDAMED ea049eba-21dc-497e-8588-71dda3a1a56e 61 fields · synced Jun 18, 2026