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Unipolar Head
EUDAMEDClass III (EU MDR)
Ref 003-3112-5051Model Biotech Modular Head System
by Biotech GmbH
Identity
- Trade Name
- Unipolar Head EUDAMED
- Model / Reference
- Biotech Modular Head System EUDAMED003-3112-5051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049852137614 EUDAMED
- Basic UDI-DI
- B-04049852137614 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
Unipolar Head by Biotech GmbH — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-04049852137614 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotech GmbH
- EUDAMED SRN
- DE-MF-000023586
Sources (1)
- EUDAMED b94f078d-d9a0-4fcd-b4f3-ccbb1aa4b19f 61 fields · synced Jul 8, 2026