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BA Femoral Stem Polished
EUDAMEDClass III (EU MDR)
Ref 001-2312-1125Model BA Hip Stem System
by Biotech GmbH
Identity
- Trade Name
- BA Femoral Stem Polished EUDAMED
- Model / Reference
- BA Hip Stem System EUDAMED001-2312-1125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049852373784 EUDAMED
- Basic UDI-DI
- B-04049852373784 EUDAMED
- EMDN Code
- P090804010101 CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT 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
BA Femoral Stem Polished 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-04049852373784 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotech GmbH
- EUDAMED SRN
- DE-MF-000023586
Sources (1)
- EUDAMED a0eeaa5f-a336-4d59-9abf-2565cf751b86 61 fields · synced Jul 8, 2026