Identity
- Trade Name
- Activa Instrument EUDAMED
- Device Name
- K-wire Ø0.8 mm, length 150 mm, blunt ends, for 4/5/6 mm interference screw EUDAMED
- Model / Reference
- B-II-0815B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394009165 EUDAMED
- Basic UDI-DI
- B-06438394009165 EUDAMED
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Activa Instrument by Bioretec Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438394009165 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (1)
- EUDAMED ccddddac-84da-48a7-987b-2e344dfc864b 61 fields · synced May 23, 2026