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Normmed CoCr Femoral Head 28 +12
EUDAMEDClass III (EU MDR)
Ref NMHFH2812Ref NMHFH2803
Identity
- Trade Name
- Normmed CoCr Femoral Head 28 +12 EUDAMEDNormmed CoCr Femoral Head 28 -3 EUDAMED
- Device Name
- Normmed CoCr Femoral Head 28 +12 EUDAMEDNormmed CoCr Femoral Head 28 -3 EUDAMED
- Model / Reference
- NMHFH2812 EUDAMEDNMHFH2803 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682549595562 EUDAMED08682549595524 EUDAMED
- Basic UDI-DI
- B-08682549595562 EUDAMEDB-08682549595524 EUDAMED
- EMDN Code
- P090804050202 METAL FEMORAL HEADS, TOTAL HIP REPLACEMENT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye 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
Category: Metallic femoral head prosthesis
Normmed CoCr Femoral Head 28 +12 by Normmed Medi̇kal San. Ve Ti̇c. A.ş. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Metallic femoral head prosthesis.
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- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- ic-head CoCrMo taper 12/14 — implantcast GmbH · 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-08682549595562 | Class III | Active |
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Manufacturer
- Manufacturer
- Normmed Medi̇kal San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000015713
Sources (2)
- EUDAMED 3935d9df-6354-4432-8fc7-a7a47295d8d7 61 fields · synced Jul 20, 2026
- EUDAMED 68819526-2eba-466a-a632-940593f1bb1e 61 fields · synced May 17, 2026