LED light curing machine
by Foshan Vimel Dental Equipment CO., LTD. EUDAMED
Active
Ref WM-CL206Model WM-i-cure,WM-P1-P5,WM-205-H,WM-Q7,Q7pro,Q5,Q5pro,WM-CL206,WM-C25 plus,WM-BS-300A,WM-YDK-CL-A1,WM-DB686,WM-211,WM-LC15
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697808746LEDlightCZ | Date30 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- LED light curing machine
- Model / Reference
- WM-i-cure, WM-P1-P5, WM-205-H, WM-Q7, Q7pro, Q5, Q5pro, WM-CL206, WM-C25 plus, WM-BS-300A, WM-YDK-CL-A1, WM-DB686, WM-211, WM-LC15
- Primary DI / UDI-DI
- 06978087460106
- Basic UDI-DI
- 697808746LEDlightCZ
- EMDN Code
- Q010299 Prosthetic dentistry devices - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000048412
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
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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