Identity
- Trade Name
- Face Reamer EUDAMED
- Device Name
- Osseointegration Surgical Instrument Set EUDAMED
- Model / Reference
- OPL-OSIS-FR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09356371011994 EUDAMED
- Basic UDI-DI
- 93563710OPL-OSIS6W EUDAMED
- EMDN Code
- L091199,L99 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Face Reamer 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-OSIS6W | 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 8fb08107-7cd3-48a7-9fca-3d9cc896792b 61 fields · synced Jun 20, 2026