Identity
- Trade Name
- LED 10W EUDAMED
- Device Name
- CURING LIGHT EUDAMED
- Model / Reference
- 04719883750617 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719883750617 EUDAMED
- Basic UDI-DI
- 471988375CuringLight7D EUDAMED
- Direct Marketing DI
- 04719883750617 EUDAMED
- EMDN Code
- Z12119003 COLD LIGHT DENTAL EQUIPMENT 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
Led 10w by Apoza Enterprise 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 | 471988375CuringLight7D | Class I | Active |
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Manufacturer
- Manufacturer
- Apoza Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000033094
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED 9986faac-968a-43ea-b828-3a6b4d64e8b3 61 fields · synced Jun 18, 2026