Identity
- Trade Name
- Intraoral Scanner EUDAMED
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- RODIS-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970940030419 EUDAMED
- Basic UDI-DI
- 69709400303Q0199TS EUDAMED
- Direct Marketing DI
- 06970940030419 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Intraoral Scanner by Foshan Roson Medical Instruments Co., 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 | 69709400303Q0199TS | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Roson Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000024527
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED d0e52332-545c-4547-8e94-bff0e2521496 61 fields · synced Jul 27, 2026