Identity
- Device Name
- Scan Gauge Kit EUDAMED
- Model / Reference
- SGK EUDAMEDSGKBE2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D102SGKBE20 EUDAMED
- Basic UDI-DI
- ++D102SGKQ5 EUDAMED
- Direct Marketing DI
- +D102SGKBE20 EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Scan Gauge Kit by Implant solutions Pty Ltd (T/A Osteon Medical) — 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 | ++D102SGKQ5 | Class I | Active |
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Manufacturer
- Manufacturer
- Implant solutions Pty Ltd (T/A Osteon Medical)
- EUDAMED SRN
- AU-MF-000030323
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 79758ccf-dab0-4114-a8f7-4c170c7d928d 61 fields · synced Jun 18, 2026