Identity
- Trade Name
- Cannulated Screwdriver BTX9 KW15 EUDAMED
- Device Name
- Strumenti chirurgici riutilizzabili accessori alle Viti per Osteosintesi EUDAMED
- Model / Reference
- STOI100009C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057717553130 EUDAMED
- Basic UDI-DI
- 805771755FT08C1BZ EUDAMED
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Cannulated Screwdriver BTX9 KW15 by BRM Extremities S.r.l. — Class I — 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 | 805771755FT08C1BZ | Class I | Active |
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Manufacturer
- Manufacturer
- BRM Extremities S.r.l.
- EUDAMED SRN
- IT-MF-000016087
Sources (1)
- EUDAMED 6fdbc9cf-28e0-45d6-8dbe-8cac46671109 61 fields · synced Jul 23, 2026