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Biotech Spinal Implant System
EUDAMEDClass IIb (EU MDR)
Ref 4049852SP1F4Model Biotech Spinal Implant System
by Biotech GmbH
Identity
- Trade Name
- Biotech Spinal Implant System EUDAMED
- Device Name
- Biotech Spinal Implant System EUDAMED
- Model / Reference
- Biotech Spinal Implant System EUDAMED4049852SP1F4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-4049852SP1F4W5 EUDAMED
- Basic UDI-DI
- B-4049852SP1F4W5 EUDAMED
- EMDN Code
- P09070101,P09070199,P09070201,P09070301,P09070302,P09070304,P09070305,P09070399,P090799 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Biotech Spinal Implant System by Biotech GmbH — Class IIb — 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-4049852SP1F4W5 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Biotech GmbH
- EUDAMED SRN
- DE-MF-000023586
Sources (1)
- EUDAMED 345292f5-89fb-4e6c-8c49-bbd739fa79de 61 fields · synced Jul 26, 2026