Identity
- Trade Name
- SmartCam EUDAMED
- Device Name
- Intraoral camera EUDAMED
- Model / Reference
- W-0020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809883170020 EUDAMED
- Basic UDI-DI
- 880988317001MY EUDAMED
- Direct Marketing DI
- 08809883170020 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
SmartCam by WINUS Technology 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 | 880988317001MY | Class I | Active |
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Manufacturer
- Manufacturer
- WINUS Technology Co., Ltd
- EUDAMED SRN
- KR-MF-000019623
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 8c317f89-c141-43af-a3b8-6013c6e163d6 61 fields · synced Jul 14, 2026