Identity
- Device Name
- LED Curing Light EUDAMED
- Model / Reference
- DB686 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974267891050 EUDAMED
- Basic UDI-DI
- 697426789105PM EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
LED Curing Light by Foshan COXO Medical Instrument Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220826 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697426789105PM | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan COXO Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001682
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 3c56a2dd-9e0e-4598-afd9-3154e909a810 85 fields · synced Jun 18, 2026
- FDA 510(k) K220826 1 fields · synced May 18, 2026