Identity
- Trade Name
- GV Adapter Screws EUDAMED
- Device Name
- Osseointegration Surgical Instrument Set EUDAMED
- Model / Reference
- OPL-GV-ADPS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09356371011765 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
GV Adapter Screws 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 a4a0ba78-404f-41cb-b264-522e35f14ffd 61 fields · synced Jul 10, 2026