Identity
- Trade Name
- Metal head Co, 12/14, D22, M EUDAMED
- Device Name
- Metal head Co, 12/14, D22, M EUDAMED
- Model / Reference
- 326722 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592602118754 EUDAMED
- Basic UDI-DI
- B-08592602118754 EUDAMED
- EMDN Code
- P090804050102 METAL FEMORAL HEADS, PARTIAL HIP REPLACEMENT EUDAMED
Classification
- Device Class
- Class III 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 Co, 12/14, D22, M by BEZNOSKA, s.r.o. — 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-08592602118754 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BEZNOSKA, s.r.o.
- EUDAMED SRN
- CZ-MF-000000543
Sources (1)
- EUDAMED a734d4d8-3b8c-4df7-a98e-b6e5b30488b1 61 fields · synced Sep 17, 2026