Dermatological Diode Laser Systems
by Zhuolu Jontelaser Manufacturing Technology Co.,Ltd. 2 variants
Ref /Model T8Pro
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06975568903022 06975568903022 | Date16 Apr 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- T8Pro, /
- Primary DI / UDI-DI
- 06975568903022
- Basic UDI-DI
- B-06975568903022
- EMDN Code
- Z120615 Therapeutic lasers
- Device Class
- Class IIb
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000017954
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Zhuolu Jontelaser Manufacturing Technology Co.,Ltd.
Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No