Identity
- Trade Name
- LED Curing light EUDAMED
- Device Name
- LED Curing light EUDAMED
- Model / Reference
- DY400-4,DY400-7 EUDAMEDDY400-7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970873260150 EUDAMED
- Basic UDI-DI
- 6970873260099BR EUDAMED
- Direct Marketing DI
- 06970873260150 EUDAMED
- EMDN Code
- Z12119003 COLD LIGHT DENTAL EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Dental/surgical polymerization lamp
LED Curing light by Denjoy Dental Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6970873260099BR | Class I | Active |
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Manufacturer
- Manufacturer
- Denjoy Dental Co., Ltd
- EUDAMED SRN
- CN-MF-000044157
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 95d7f886-ed99-4788-80b5-fb8006ab0d44 61 fields · synced Jul 14, 2026