Bracket
by Zhejiang Shinye Medical Technology Corp., Ltd. 979 variants
Ref 8218-20B-41-10Model Standard Confidence Brackets (Roth*)
Bracket (8218-20B-41-10) is a Class IIa device made by Zhejiang Shinye Medical Technology Corp., Ltd., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-06942054790701), active as of 7 Nov 2026.
Active
CE MDD
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/MDD | NumberB-06942054790701 06942054790701 | Date2 Nov 2026 | StatusActive |
Official records
- EUDAMED public site B-06942054790701
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / reference
- Standard Confidence Brackets (Roth*), 8218-20B-41-10
- Primary DI / UDI-DI
- 06942054790701
- Basic UDI-DI
- B-06942054790701
- EMDN code
- Q010403 Orthodontic brackets and buttons
- Device class
- Class IIa
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000023934
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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