Identity
- Trade Name
- Dilator for 2.0 mm intramedullary nail EUDAMEDActiva Instrument EUDAMED
- Device Name
- Dilator EUDAMEDDilator for 2.0 mm intramedullary nail EUDAMED
- Model / Reference
- B-INIM-2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394011533 EUDAMED
- Basic UDI-DI
- 6438394INS018WX EUDAMEDB-06438394011533 EUDAMED
- Direct Marketing DI
- 06438394011533 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
Dilator for 2.0 mm intramedullary nail 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 | 6438394INS018WX | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438394INS018WX | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED efca8ce3-03eb-44fa-940b-4d32e1b6a4b6 61 fields · synced Jun 17, 2026
- EUDAMED 2d13f696-1cf3-4e7b-bd3b-332519227a27 61 fields · synced May 18, 2026