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Activa IM-Nail™
EUDAMEDClass III (EU MDR)
Ref B-ANIM-32200Ref B-ANIM-20400Ref B-ANIM-27400Ref B-ANIM-27200Ref B-ANIM-20300
Identity
- Trade Name
- Activa IM-Nail™ EUDAMED
- Device Name
- Activa IM-Nail™ 3.2 x 200 mm EUDAMEDActiva IM-Nail™ 2.0 x 400 mm EUDAMEDActiva IM-Nail™ 2.7 x 400 mm EUDAMEDActiva IM-Nail™ 2.7 x 200 mm EUDAMEDActiva IM-Nail™ 2.0 x 300 mm EUDAMED
- Model / Reference
- B-ANIM-32200 EUDAMEDB-ANIM-20400 EUDAMEDB-ANIM-27400 EUDAMEDB-ANIM-27200 EUDAMEDB-ANIM-20300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394011502 EUDAMED06438394008786 EUDAMED06438394007291 EUDAMED06438394011489 EUDAMED06438394011472 EUDAMED
- Basic UDI-DI
- B-06438394011502 EUDAMEDB-06438394008786 EUDAMEDB-06438394007291 EUDAMEDB-06438394011489 EUDAMEDB-06438394011472 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
Activa IM-Nail™ 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-06438394011502 | Class III | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (5)
- EUDAMED 635cce78-c05e-404b-90b8-9b25156d3ef5 61 fields · synced Aug 4, 2026
- EUDAMED 1970285b-4b19-4ff7-8b5e-2551308343b4 61 fields · synced May 11, 2026
- EUDAMED 7a958738-2bc1-469d-8bca-bee6ece530f6 61 fields · synced May 17, 2026
- EUDAMED 733d19a8-1f08-4f55-8945-007f1878deed 61 fields · synced May 17, 2026
- EUDAMED 91cd4bab-5669-4d58-838e-daef89d06566 61 fields · synced May 17, 2026