Identity
- Trade Name
- Activa Instrument EUDAMEDDilator for 2.7 mm intramedullary nail EUDAMED
- Device Name
- Dilator for 2.7 mm intramedullary nail EUDAMEDDilator EUDAMED
- Model / Reference
- B-INIM-2700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394011526 EUDAMED
- Basic UDI-DI
- B-06438394011526 EUDAMED6438394INS018WX EUDAMED
- Direct Marketing DI
- 06438394011526 EUDAMED
- EMDN Code
- L0925 ORTHOPAEDIC SURGERY DILATORS, 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438394011526 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-06438394011526 | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 0fe567a4-4e65-498a-8373-d7bf8b4beb20 61 fields · synced Sep 18, 2026
- EUDAMED 1a45e897-0b70-49d8-b8d7-9e0f3ed4e9d6 61 fields · synced May 17, 2026