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bracket - EUDAMED Registration 06942054773360

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 06942054773360 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.

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EUDAMED Official Data
Class IIa
06942054773360
No
bracket
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

ORTHODONTIC BRACKETS AND BUTTONS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q010403
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06942054773360
Basic UDI
B-06942054773360
Version Date
February 12, 2025
Manufacturer Last Update
May 16, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No. 1032 Tongyi Rd., Gongshu District Hangzhou
Email
gd@shinye-ortho.com
Authorized Representative
SRN
NL-AR-000000121
Country
Netherlands
Address
Koningin Julianaplein 10, 1e Verd The Hague
Email
info@lotusnl.com
Regulatory Information
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
Device Characteristics
Human Tissues
No
Animal Tissues
No