Identity
- Trade Name
- ActivaScrew™ Cannulated EUDAMED
- Device Name
- ActivaScrew™ Cannulated 3.5 x 20 mm EUDAMED
- Model / Reference
- B-ASC-3520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394001596 EUDAMED
- Basic UDI-DI
- B-06438394001596 EUDAMED
- EMDN Code
- P09120606 OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
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
ActivaScrew™ Cannulated by Bioretec Ltd. — Class III — 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-06438394001596 | Class III | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (1)
- EUDAMED 11849832-b8f2-4735-a9c1-c493a72b84b7 61 fields · synced May 23, 2026