NiTi Orthodontic Wire
by Beijing Smart Technology Co., Ltd. 55 variants
Ref SE-R-1725-U, SE-RC-R-1725-L, SM-R-1625-U, SE-RC-R-1420-U, SE-RC-D-14-L, SE-R-2125-L, SM-R-1814-L, SE-R-1814-L, SE-RC-R-2125-U, SM-R-1822-L, SE-R-1717-L, SE-R-2020-L, SE-R-2125-U, SE-RC-R-1717-L
Active
CE MDR
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/MDR | Number69417841NTWIRE56 | Date16 Jun 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- Nitinol (NiTi) Orthodontic Wires
- Device Name
- NiTi Orthodontic Wire
- Model / Reference
- SE-R-1725-U, SE-RC-R-1725-L, SM-R-1625-U, SE-RC-R-1420-U, SE-RC-D-14-L, SE-R-2125-L, SM-R-1814-L, SE-R-1814-L, SE-RC-R-2125-U, SM-R-1822-L, SE-R-1717-L, SE-R-2020-L, SE-R-2125-U, SE-RC-R-1717-L
- Primary DI / UDI-DI
- 06941784100255, 06941784101023, 06941784100590, 06941784111688, 06941784100842, 06941784100385, 06941784104086, 06941784104062, 06941784101139, 06941784100682, 06941784104048, 06941784100361, 06941784100378, 06941784111411
- Basic UDI-DI
- 69417841NTWIRE56, B-06941784101023, B-06941784101139, B-06941784100255
- EMDN Code
- Q010405 Orthodontic wires
- Device Class
- Class IIa
- EU market of registration
- FranceItaly
Manufacturer details
- EUDAMED SRN
- CN-MF-000015988
- Authorised representative
- Eunitor GmbH DE-AR-000005081
Other devices from Beijing Smart 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