Identity
- Trade Name
- APOZA EUDAMEDFDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- Ozone Generator EUDAMEDLED CURING LIGHT: 5W. FDA UDI
- Model / Reference
- Ozone DTA J500 EUDAMED04719883750334 EUDAMEDMega Light CL FDA UDI
- Description
- LED CURING LIGHT: 5W. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719883750334 EUDAMED04719883751515 FDA UDI
- Basic UDI-DI
- B-04719883750334 EUDAMED
- 510(k) Number
- K041303 FDA UDI
- FDA Product Code
- EBZ FDA UDI
- EMDN Code
- Z12040207 OZONE THERAPY EQUIPMENT EUDAMED
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6070 FDA UDI
- Market of Registration
- Italy 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Apoza by Apoza Enterprise Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719883750334 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 5ed88658-13bb-4b3a-a8df-e5d8cc838a0b 61 fields · synced Jul 9, 2026
- FDA UDI ac970827-aa42-4ca2-9f6c-a31da06d0c85 34 fields · synced May 26, 2026