Identity
- Trade Name
- RayCam EUDAMED
- Device Name
- Intraoral camera EUDAMED
- Model / Reference
- W-0006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809883170006 EUDAMED
- Basic UDI-DI
- 880988317001MY EUDAMED
- Direct Marketing DI
- 08809883170006 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
RayCam 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 b1e5ad61-caac-4185-aea0-b51778df2041 61 fields · synced Jun 18, 2026