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Scan Gauge Kit
EUDAMEDClass I (EU MDR)
Ref SGKAAModel SGKRef SGKAORef SGKAXRef SGKAA2Ref SGKBF2Ref SGKAGRef SGKAFRef SGKAPRef SGKBBRef SGKBG2Ref SGKAYRef SGKAZRef SGKAURef SGKBARef SGKAWRef SGKABRef SGKANRef SGKATRef SGKAIRef SGKAD
Identity
- Device Name
- Scan Gauge Kit EUDAMED
- Model / Reference
- SGK EUDAMEDSGKAA EUDAMEDSGKAO EUDAMEDSGKAX EUDAMEDSGKAA2 EUDAMEDSGKBF2 EUDAMEDSGKAG EUDAMEDSGKAF EUDAMEDSGKAP EUDAMEDSGKBB EUDAMEDSGKBG2 EUDAMEDSGKAY EUDAMEDSGKAZ EUDAMEDSGKAU EUDAMEDSGKBA EUDAMEDSGKAW EUDAMEDSGKAB EUDAMEDSGKAN EUDAMEDSGKAT EUDAMEDSGKAI EUDAMEDSGKAD EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D102SGKAA0 EUDAMED+D102SGKAO0 EUDAMED+D102SGKAX0 EUDAMED+D102SGKAA20 EUDAMED+D102SGKBF20 EUDAMED+D102SGKAG0 EUDAMED+D102SGKAF0 EUDAMED+D102SGKAP0 EUDAMED+D102SGKBB0 EUDAMED+D102SGKBG20 EUDAMED+D102SGKAY0 EUDAMED+D102SGKAZ0 EUDAMED+D102SGKAU0 EUDAMED+D102SGKBA0 EUDAMED+D102SGKAW0 EUDAMED+D102SGKAB0 EUDAMED+D102SGKAN0 EUDAMED+D102SGKAT0 EUDAMED+D102SGKAI0 EUDAMED+D102SGKAD0 EUDAMED
- Basic UDI-DI
- ++D102SGKQ5 EUDAMED
- Direct Marketing DI
- +D102SGKAA0 EUDAMED+D102SGKAO0 EUDAMED+D102SGKAX0 EUDAMED+D102SGKAA20 EUDAMED+D102SGKBF20 EUDAMED+D102SGKAG0 EUDAMED+D102SGKAF0 EUDAMED+D102SGKAP0 EUDAMED+D102SGKBB0 EUDAMED+D102SGKBG20 EUDAMED+D102SGKAY0 EUDAMED+D102SGKAZ0 EUDAMED+D102SGKAU0 EUDAMED+D102SGKBA0 EUDAMED+D102SGKAW0 EUDAMED+D102SGKAB0 EUDAMED+D102SGKAN0 EUDAMED+D102SGKAT0 EUDAMED+D102SGKAI0 EUDAMED+D102SGKAD0 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 (20)
- EUDAMED cd686e7c-5642-4291-907b-a33436288f04 61 fields · synced Oct 6, 2026
- EUDAMED d790250a-b9f6-4fa9-bb68-80b0da3041a6 61 fields · synced May 16, 2026
- EUDAMED 5e41ad52-9247-40ea-8b33-ecc347fd2d00 61 fields · synced May 16, 2026
- EUDAMED 6d11344f-20c5-4cfd-a095-95ca45c4a235 61 fields · synced May 16, 2026
- EUDAMED b2ca3436-75e9-4ae9-8af0-91822809f9b1 61 fields · synced May 16, 2026
- EUDAMED c333dee9-9f9b-41f1-ae1b-c9b3ef9f9a0d 61 fields · synced May 16, 2026
- EUDAMED ac1e1017-2c96-4c64-a4dc-80e84dcfec49 61 fields · synced May 16, 2026
- EUDAMED 014b3533-8832-45d8-a048-209c8705b9d9 61 fields · synced May 16, 2026
- EUDAMED 481cbb75-c436-477a-8c24-501a96458c2d 61 fields · synced May 17, 2026
- EUDAMED a3cc9524-da6b-43fe-9ad5-3ebc5e4f00b3 61 fields · synced May 17, 2026
- EUDAMED 0694c206-d671-456c-b534-cf655b663ec4 61 fields · synced May 17, 2026
- EUDAMED 07c56597-5d68-4824-9f47-836b6d39ca40 61 fields · synced May 17, 2026
- EUDAMED 94b79609-4c76-412b-988e-ce666396e60b 61 fields · synced May 18, 2026
- EUDAMED 148f55c8-9118-4fd9-bbe9-5a9c29d3af13 61 fields · synced May 18, 2026
- EUDAMED a42c925c-717d-448f-baec-713951bc4b04 61 fields · synced May 18, 2026
- EUDAMED fe80b83f-16b8-4ef2-9840-3d3cd1657c90 61 fields · synced May 18, 2026
- EUDAMED ee4d0412-d768-4e72-9cfb-44494259d3b2 61 fields · synced May 18, 2026
- EUDAMED 07875bf8-1f9e-43f8-90c4-de2203c99480 61 fields · synced May 18, 2026
- EUDAMED f08e8388-92ed-4bbe-b4b8-34221e69608a 61 fields · synced May 18, 2026
- EUDAMED 6a10d082-ae8b-41e6-afed-caf6744dcce8 61 fields · synced May 19, 2026