Orthodontic bracket
by Zhejiang Risheng Medical Technology Co., Ltd 103 variants
Ref BQR1-2044Model Ligating
Orthodontic bracket (BQR1-2044) 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 06971464937048 | 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- Withdrawn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, BQR1-2044
- Primary DI / UDI-DI
- 06971464937048
- Basic UDI-DI
- 697146493BL2K
- Direct marketing DI
- 06971464937048
- 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
Similar devices in this category
Other devices filed under ORTHODONTIC BRACKETS AND BUTTONS.
- Orthodontic Brackets F2082C31 by LEONE S.P.A.
- Orthodontic Brackets F4281-903 by LEONE S.P.A.
- L6R DBT DB/UL 18 ROTH MT HK -1/-30/4 437-0014 by Ormco Corporation
- MINI DIAMOND TWN LR1BI W/HK -11T 0A 018 350-1612 by Ormco Corporation
- 3M™ Unitek™ Victory Series™ MBT™ 017-790 by 3m do Brasil Ltda.
- APC™ PLUS Unitek™ Mini Uni-Twin 5020-467 by 3M UNITEK CORPORATION
- APC™ PLUS Clarity™ ADVANCED 5006-121 by 3M UNITEK CORPORATION
- HORIZON MINI TWIN BRACKET .018 ROTH 5X5 W/HKS ON 3'S ONLY LN2-903 by Ortho Arch Company
- Buccal Tubes 908.1008-5 by World Class Technology Corporation
- HORIZON MINI TWIN BRACKET .022 LBICL -17T LN3-174 by Ortho Arch Company
Other devices from Zhejiang Risheng Medical Technology Co., Ltd
See all devices from Zhejiang Risheng Medical Technology Co., Ltd →