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BA BIOTAN Femoral Stem w. TPS coating
EUDAMEDClass III (EU MDR)
Ref 001-1115-1500Model BA Hip Stem System
by Biotech GmbH
Identity
- Trade Name
- BA BIOTAN Femoral Stem w. TPS coating EUDAMED
- Model / Reference
- BA Hip Stem System EUDAMED001-1115-1500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049852005951 EUDAMED
- Basic UDI-DI
- B-04049852005951 EUDAMED
- EMDN Code
- P090804010201 UNCEMENTED 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 BIOTAN Femoral Stem w. TPS coating 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-04049852005951 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotech GmbH
- EUDAMED SRN
- DE-MF-000023586
Sources (1)
- EUDAMED 792ba501-d58d-4546-8396-ca60f8f0808c 61 fields · synced Jul 8, 2026