Identity
- Trade Name
- Inserter for intramedullary nail EUDAMEDActiva Instrument EUDAMED
- Device Name
- Inserter EUDAMEDInserter for intramedullary nail EUDAMED
- Model / Reference
- B-INIM-4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394007314 EUDAMED
- Basic UDI-DI
- 6438394INS017WV EUDAMEDB-06438394007314 EUDAMED
- Direct Marketing DI
- 06438394007314 EUDAMED
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Inserter for intramedullary nail by Bioretec Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438394INS017WV | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438394INS017WV | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED e42cccbe-45a0-43f4-a9bd-7be363f81d7d 61 fields · synced Jul 24, 2026
- EUDAMED 0473af81-763d-4c2f-8be8-67ebd086b78e 61 fields · synced May 18, 2026