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Biotech Modular Revision Hip - distal component w. TPS coating
EUDAMEDClass III (EU MDR)
Ref 024-1111-1203Model Biotech Modular Revision Hip Stem System
by Biotech GmbH
Identity
- Trade Name
- Biotech Modular Revision Hip - distal component w. TPS coating EUDAMED
- Model / Reference
- Biotech Modular Revision Hip Stem System EUDAMED024-1111-1203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049852209229 EUDAMED
- Basic UDI-DI
- B-04049852209229 EUDAMED
- EMDN Code
- P090804030202 REVISION UNCEMENTED FEMORAL STEMS, WITH MODULAR NECK 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
Biotech Modular Revision Hip - distal component 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-04049852209229 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotech GmbH
- EUDAMED SRN
- DE-MF-000023586
Sources (1)
- EUDAMED 23457984-2af3-40bc-966f-99488793a422 61 fields · synced Sep 30, 2026