Identity
- Trade Name
- Activa Instrument EUDAMEDDirect driver, for 3.5 mm cannulated screws EUDAMED
- Device Name
- Direct driver, for 3.5 mm cannulated screws EUDAMEDDirect Driver EUDAMED
- Model / Reference
- B-ISC-3502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394005228 EUDAMED
- Basic UDI-DI
- B-06438394005228 EUDAMED6438394INS009WW EUDAMED
- Direct Marketing DI
- 06438394005228 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
Activa Instrument by Bioretec Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438394005228 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438394005228 | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 329ffe5b-775c-4e50-99b8-ac4197ab77c1 61 fields · synced Jul 10, 2026
- EUDAMED ca431811-def8-4cd0-9fc4-db3e4c011552 61 fields · synced May 17, 2026