LED Curing Light
by Foshan Topmed Dental Co., Ltd EUDAMED
Active
Ref TM-E0005Model TOPCURE X、TOPCURE、TOPCURE B-U、TOPCURE B-E、TOPCURE B-24V、TM-E0005、TM-E0007、TM-E0008
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number698014095LCLPR | Date26 Aug 2026 | 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- Withdrawn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 Curing Light
- Model / Reference
- TOPCURE X、TOPCURE、TOPCURE B-U、TOPCURE B-E、TOPCURE B-24V、TM-E0005、TM-E0007、TM-E0008, TM-E0005
- Primary DI / UDI-DI
- 06980140953067
- Basic UDI-DI
- 698014095LCLPR
- EMDN Code
- Q010199 Conservative dentistry and endodontics devices - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000057253
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Foshan Topmed Dental 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