Identity
- Trade Name
- Metal head, 12/14, D40 EUDAMED
- Device Name
- Metal head, 12/14, D40 EUDAMED
- Model / Reference
- 324602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592602118167 EUDAMED
- Basic UDI-DI
- B-08592602118167 EUDAMED
- EMDN Code
- P090804050102 METAL FEMORAL HEADS, PARTIAL HIP REPLACEMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia 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
Metal head, 12/14, D40 by BEZNOSKA, s.r.o. — Class IIb — 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
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-08592602118167 | Class IIb | Active |
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Manufacturer
- Manufacturer
- BEZNOSKA, s.r.o.
- EUDAMED SRN
- CZ-MF-000000543
Sources (1)
- EUDAMED cdd715e2-a9ad-4f67-9594-aa546c83bb8f 61 fields · synced Jun 11, 2026