Identity
- Trade Name
- Activa Instrument EUDAMEDNotcher for interference screw EUDAMED
- Device Name
- Notcher for interference screw EUDAMEDNotcher EUDAMED
- Model / Reference
- B-II-8010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394008755 EUDAMED
- Basic UDI-DI
- B-06438394008755 EUDAMED6438394INS014WP EUDAMED
- Direct Marketing DI
- 06438394008755 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 — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438394008755 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438394008755 | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 8670c7d6-2a54-4c42-b831-58456b4144b3 61 fields · synced Jul 9, 2026
- EUDAMED 8f3b985e-91b9-43f2-8caf-e5f9533bc817 61 fields · synced May 17, 2026