Identity
- Trade Name
- HEX shaft, for 3.5 mm cannulated screws EUDAMEDActiva Instrument EUDAMED
- Device Name
- Hex Driver EUDAMEDHEX shaft, for 3.5 mm cannulated screws EUDAMED
- Model / Reference
- B-ISC-9032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394005204 EUDAMED
- Basic UDI-DI
- 6438394INS012WK EUDAMEDB-06438394005204 EUDAMED
- Direct Marketing DI
- 06438394005204 EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE 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
Category: Surgical screwdriver, reusable
HEX shaft, for 3.5 mm cannulated screws by Bioretec Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6438394INS012WK | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438394INS012WK | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 291394d1-4d46-421f-bfa9-eb4aa4747344 61 fields · synced Jul 25, 2026
- EUDAMED facff624-e7e1-42b7-b64e-46eaa7a55db6 61 fields · synced May 19, 2026