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Unipolar Head
EUDAMEDClass III (EU MDR)
Ref 003-2112-5039Model Biotech Modular Head System
by Biotech GmbH
Identity
- Trade Name
- Unipolar Head EUDAMED
- Model / Reference
- Biotech Modular Head System EUDAMED003-2112-5039 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049852137706 EUDAMED
- Basic UDI-DI
- B-04049852137706 EUDAMED
- EMDN Code
- P090804050202 METAL FEMORAL HEADS, TOTAL HIP REPLACEMENT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
Unipolar Head by Biotech GmbH — 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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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-04049852137706 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotech GmbH
- EUDAMED SRN
- DE-MF-000023586
Sources (1)
- EUDAMED cebd2e51-04b9-4666-a9ea-17587ab1a6a4 61 fields · synced Jul 8, 2026