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Double drill sleeve Ø1.5/2.0 mm, for 2.0mm screws
EUDAMEDClass I (EU MDR)
Ref B-IS-2005Ref B-IS-2005
Identity
- Trade Name
- Double drill sleeve Ø1.5/2.0 mm, for 2.0mm screws EUDAMEDActiva Instrument EUDAMED
- Device Name
- Drill Sleeve / Guide EUDAMEDDouble drill sleeve Ø1.5/2.0 mm, for 2.0mm screws EUDAMED
- Model / Reference
- B-IS-2005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394001480 EUDAMED
- Basic UDI-DI
- 6438394INS010WF EUDAMEDB-06438394001480 EUDAMED
- Direct Marketing DI
- 06438394001480 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
Double drill sleeve Ø1.5/2.0 mm, for 2.0mm screws 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 | 6438394INS010WF | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438394INS010WF | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED 6e718d3b-c740-47a6-8a01-3531b6a09161 61 fields · synced Jun 18, 2026
- EUDAMED 2e843624-c01a-4a3e-93e8-29fcafed9766 61 fields · synced May 18, 2026