Identity
- Trade Name
- Activa Instrument EUDAMEDProtection sheath EUDAMED
- Device Name
- Protection sheath EUDAMEDDrill Sleeve / Guide EUDAMED
- Model / Reference
- B-IS-6505 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394001527 EUDAMED
- Basic UDI-DI
- B-06438394001527 EUDAMED6438394INS010WF EUDAMED
- Direct Marketing DI
- 06438394001527 EUDAMED
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, 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-06438394001527 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438394001527 | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED c28a39da-ec03-4f0a-9bb5-c9f5a013b25c 61 fields · synced Jun 18, 2026
- EUDAMED 464776af-938a-46f9-af0c-bfc04d659eda 61 fields · synced May 17, 2026