Orthodontic bracket
by Zhejiang Risheng Medical Technology Co., Ltd 103 variants
Ref BQR1-2125Model Ligating
Orthodontic bracket (BQR1-2125) is a Class IIa device made by Zhejiang Risheng Medical Technology Co., Ltd, registered in EUDAMED on 5 Nov 2025 (Basic UDI-DI 697146493BL2K), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697146493BL2K 06971464937130 | Date5 Nov 2025 | StatusActive |
Official records
- EUDAMED public site 697146493BL2K
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Orthodontic bracket
- Model / reference
- Ligating, BQR1-2125
- Primary DI / UDI-DI
- 06971464937130
- Basic UDI-DI
- 697146493BL2K
- Direct marketing DI
- 06971464937130
- EMDN code
- Q010403 Orthodontic brackets and buttons
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000011127
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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