Identity
- Device Name
- DIAMOND™ Co-Cr-Mo Femoral Head EUDAMED
- Model / Reference
- C32213605 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921814256114 EUDAMED
- Basic UDI-DI
- B-06921814256114 EUDAMED
- EMDN Code
- P090804050202 METAL FEMORAL HEADS, TOTAL HIP REPLACEMENT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Portugal 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
DIAMOND™ Co-Cr-Mo Femoral Head by Tianjin Zhengtian Medical Instrument Co., Ltd. — Class III — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Metallic femoral head prosthesis.
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- 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-06921814256114 | Class III | Active |
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Manufacturer
- Manufacturer
- Tianjin Zhengtian Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000020115
- Authorised Representative
- Inion Oy FI-AR-000046224
Sources (1)
- EUDAMED 87d168b1-3e75-4f8f-b659-6f54f9ed0420 61 fields · synced Oct 7, 2026