3-LAYERS THERMOPLASTIC DISCS 0, 80mmx120 ROUND
by Orthodontics High Design SRL 4 variants
Ref TP3-125-25Model 3FLEX CLEAR
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 | Number8050593783FLEXCLEARRZ 08050593780553 | Date28 May 2024 | 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- Withdrawn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
- 3-LAYERS THERMOPLASTIC DISCS 0,80mmx120 ROUND
- Model / Reference
- 3FLEX CLEAR, TP3-125-25
- Primary DI / UDI-DI
- 08050593780553
- Basic UDI-DI
- 8050593783FLEXCLEARRZ
- Direct Marketing DI
- 08050593780553
- EMDN Code
- Q010499 Orthodontic devices - other
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000020077
Other devices from Orthodontics High Design SRL
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