Rayshape
by Suzhou Laixin 3D Technology Co., Ltd. 11 variants
Ref Model Pro
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 | Number697845290190MPGAB | Date3 Sep 2026 | 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- Withdrawn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
- Model Resin
- Model / Reference
- Model Pro
- Primary DI / UDI-DI
- 06978452900190, 06978452900152, 06978452900206, 06978452900176, 06978452900060, 06978452900169
- Basic UDI-DI
- 697845290190MPGAB, 697845290152MPI9H, 697845290206MPO9F, 697845290176MPOBF, 697845290060MPI8Z, 697845290169MPGB9
- EMDN Code
- Q0102050199 Dentistry resins - other
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000058405
- Authorised representative
- TRANSMED GLOBAL CONSULTING, S.L. ES-AR-000044598
Other devices from Suzhou Laixin 3D Technology Co., Ltd.
See all devices from Suzhou Laixin 3D Technology 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