E-MorLit
by Apoza Enterprise Co., Ltd. 3 variants
Ref 04719883750501
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number471988375CuringLight7D 04719883750501 | Date17 Apr 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Curing Light
- Model / Reference
- 04719883750501
- Primary DI / UDI-DI
- 04719883750501
- Basic UDI-DI
- 471988375CuringLight7D
- Direct Marketing DI
- 04719883750501
- EMDN Code
- Z12119003 Cold light dental equipment
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000033094
- Authorised representative
- Luana Med. B.V. NL-AR-000002750
Other devices from Apoza Enterprise Co., Ltd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No