Identity
- Trade Name
- TOP 5W EUDAMEDAPOZA FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- CURING LIGHT EUDAMEDLED CURING LIGHT: 5W. FDA UDI
- Model / Reference
- 04719883750860 EUDAMEDTOP 5W FDA UDI
- Description
- LED CURING LIGHT: 5W. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719883750860 EUDAMEDFDA UDI
- Basic UDI-DI
- 471988375CuringLight7D EUDAMED
- Direct Marketing DI
- 04719883750860 EUDAMED
- 510(k) Number
- K070373 FDA UDI
- FDA Product Code
- EBZ FDA UDI
- EMDN Code
- Z12119003 COLD LIGHT DENTAL EQUIPMENT EUDAMED
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6070 FDA UDI
- Market of Registration
- Slovakia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental/surgical polymerization lamp
Top 5w by Apoza Enterprise Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471988375CuringLight7D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 30c9bc8f-dbca-4f4e-a600-b382b8b665e9 61 fields · synced Jul 9, 2026
- FDA UDI f567b8cc-4d23-484c-a571-a87fbf1904a6 34 fields · synced May 30, 2026