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E-MorLit
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 04719883750563Ref 04719883750501510(k) K070373
Identity
- Trade Name
- E-MorLit EUDAMED
- Device Name
- CURING LIGHT EUDAMED
- Model / Reference
- 04719883750563 EUDAMED04719883750501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719883750563 EUDAMED04719883750501 EUDAMED
- Basic UDI-DI
- 471988375CuringLight7D EUDAMED
- Direct Marketing DI
- 04719883750563 EUDAMED04719883750501 EUDAMED
- 510(k) Number
- K070373 FDA 510(k)
- FDA Product Code
- EBZ FDA 510(k)
- EMDN Code
- Z12119003 COLD LIGHT DENTAL EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6070 FDA 510(k)
- Regulation Number
- 872.6070 FDA 510(k)
- Market of Registration
- Italy EUDAMEDGermany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
E-MorLit by Apoza Enterprise Co., Ltd. — Class I — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 471988375CuringLight7D | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K070373 | Class I | Active |
| 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 (3)
- EUDAMED 30415b23-7768-4e6a-b8c3-eb49e9db224c 61 fields · synced Jul 10, 2026
- EUDAMED 175036df-847a-4b34-bf93-ff0ff66af609 61 fields · synced May 18, 2026
- FDA 510(k) K070373 24 fields · synced May 18, 2026