Orthodontic traction device
by Zhejiang Risheng Medical Technology Co., Ltd EUDAMED
Active
Ref A52-12SbModel Face mask
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697146493A5SR4 | Date30 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- Orthodontic traction device
- Model / Reference
- Face mask, A52-12Sb
- Primary DI / UDI-DI
- 06971464931190
- Basic UDI-DI
- 697146493A5SR4
- Direct Marketing DI
- 06971464931190
- EMDN Code
- Q010401 Orthodontic face bows
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000011127
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Zhejiang Risheng Medical Technology Co., Ltd
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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