Identity
- Trade Name
- Bushing EUDAMED
- Device Name
- Lower Limb Connector EUDAMED
- Model / Reference
- OPL-LLC-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09356371001643 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
Bushing 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 2568d886-2020-418c-ba66-0e0e819c61aa 61 fields · synced Jul 9, 2026