Identity
- Trade Name
- Bioplan - Trial Size 10 EUDAMED
- Device Name
- Strumenti chirurgici accessori all'impianto dei dispositivi Bioplan EUDAMED
- Model / Reference
- SBPI10P010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057717553680 EUDAMED
- Basic UDI-DI
- 805771755FT09B4C9 EUDAMED
- EMDN Code
- V0607 OSTEOSYNTHESIS IMPLANTS TESTING DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Bioplan - Trial Size 10 by BRM Extremities S.r.l. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805771755FT09B4C9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BRM Extremities S.r.l.
- EUDAMED SRN
- IT-MF-000016087
Sources (1)
- EUDAMED 346eab98-6ab5-4971-8f55-fe6061fc4799 61 fields · synced Jul 9, 2026