Identity
- Trade Name
- Activa Instrument EUDAMEDDouble drill sleeve Ø2.5/3.5 mm, for 3.5mm screws EUDAMED
- Device Name
- Double drill sleeve Ø2.5/3.5 mm, for 3.5mm screws EUDAMEDDrill Sleeve / Guide EUDAMED
- Model / Reference
- B-IS-3505 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394001503 EUDAMED
- Basic UDI-DI
- B-06438394001503 EUDAMED6438394INS010WF EUDAMED
- Direct Marketing DI
- 06438394001503 EUDAMED
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, 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
Activa Instrument by Bioretec Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06438394001503 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438394001503 | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 90410afe-ef80-45a2-8d65-66060257c361 61 fields · synced Jul 29, 2026
- EUDAMED 7a8aefd3-33b6-4664-bd60-0e7f6af3c953 61 fields · synced May 17, 2026