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Tête Inox diamètre 28 Col Extra Court -5 mm
EUDAMEDClass III (EU MDR)
Ref 13-04-28-00Model tête métalliqueRef 13-04-28-01
Identity
- Trade Name
- Tête Inox diamètre 28 Col Extra Court -5 mm EUDAMEDTête Inox diamètre 28 Col Court -3.5 mm EUDAMED
- Device Name
- stainless steel femoral head EUDAMED
- Model / Reference
- tête métallique EUDAMED13-04-28-00 EUDAMED13-04-28-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EPRS13042800A0 EUDAMEDEPRS13042801A0 EUDAMED
- Basic UDI-DI
- B-EPRS13042800A0 EUDAMEDB-EPRS13042801A0 EUDAMED
- EMDN Code
- P090804050202 METAL 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
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
Category: Metallic femoral head prosthesis
Tête Inox diamètre 28 Col Extra Court -5 mm by Protheos Industrie — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Metallic femoral head prosthesis.
- Normmed CoCr Femoral Head 28 +12 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- Orthinox — Howmedica Osteonics Corp. · Class II
- A110212031 — EUROS SAS · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
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-EPRS13042800A0 | Class III | Active |
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Manufacturer
- Manufacturer
- Protheos Industrie
- EUDAMED SRN
- FR-MF-000000150
Sources (2)
- EUDAMED dc34d32e-84cf-4b45-b580-aaac200efbac 61 fields · synced Jun 20, 2026
- EUDAMED 27acb5cd-005d-4b1e-a174-446a043562d1 61 fields · synced May 18, 2026