Identity
- Trade Name
- Activa IM-Nail™ EUDAMED
- Device Name
- Activa IM-Nail™ 2.0 x 200 mm EUDAMED
- Model / Reference
- B-ANIM-20200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394011441 EUDAMED
- Basic UDI-DI
- B-06438394011441 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS 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
Category: Arthrodesis intramedullary nail, non-distracting
Activa IM-Nail™ by Bioretec Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Arthrodesis intramedullary nail, non-distracting.
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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-06438394011441 | Class III | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (1)
- EUDAMED cc67ef2f-f908-4066-aeb3-3bd7f03aaff1 61 fields · synced Jun 19, 2026