Identity
- Trade Name
- 5mm Hex Distal Locking Screw – M10 EUDAMED
- Device Name
- Lower Limb Connector EUDAMED
- Model / Reference
- OPL-LLCM10-DLS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09356371001650 EUDAMED
- Basic UDI-DI
- 93563710OPL-LLCVF EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
5mm Hex Distal Locking Screw – M10 by Osseointegration International Pty Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 93563710OPL-LLCVF | Class I | Active |
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Manufacturer
- Manufacturer
- Osseointegration International Pty Ltd
- EUDAMED SRN
- AU-MF-000014557
- Authorised Representative
- Easy Medical Device BE-AR-000011902
Sources (1)
- EUDAMED 764d8b7b-ea2b-4a51-8cdf-1d2e9fa3e0c2 61 fields · synced Jul 9, 2026