bracket
- Risk class
- Class IIa
- CND nomenclatures code
- Q010403
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06942054773278
- Basic UDI
- B-06942054773278
- Version date
- February 11, 2025
- Manufacturer last update
- May 16, 2022
- Active status
- No
- Manufacturer name
- Zhejiang Shinye Medical Technology Corp. , Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- No. 1032 Tongyi Rd., Gongshu District Hangzhou
- gd@shinye-ortho.com
- Name
- Lotus NL B.V.
- SRN
- NL-AR-000000121
- Country
- Netherlands
- Address
- Koningin Julianaplein 10, 1e Verd The Hague
- info@lotusnl.com
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- Netherlands
- Market available
- Netherlands:2016-01-01~None
- Human tissues
- No
- Animal tissues
- No
ORTHODONTIC BRACKETS AND BUTTONS
Access comprehensive regulatory information for bracket in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06942054773278 and manufactured by Zhejiang Shinye Medical Technology Corp. , Ltd. in China.
This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.