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Tête Inox diamètre 28 Col Extra Long +7 mm
EUDAMEDClass III (EU MDR)
Ref 13-04-28-04Model tête métallique
Identity
- Trade Name
- Tête Inox diamètre 28 Col Extra Long +7 mm EUDAMED
- Device Name
- stainless steel femoral head EUDAMED
- Model / Reference
- tête métallique EUDAMED13-04-28-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EPRS13042804A0 EUDAMED
- Basic UDI-DI
- B-EPRS13042804A0 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 Long +7 mm by Protheos Industrie — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Metallic femoral head prosthesis.
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- 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-EPRS13042804A0 | Class III | Active |
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Manufacturer
- Manufacturer
- Protheos Industrie
- EUDAMED SRN
- FR-MF-000000150
Sources (1)
- EUDAMED ef9c2399-5200-4d74-a618-9ea18b3258f5 61 fields · synced Oct 6, 2026