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Buccal Tubes - EUDAMED Registration 06936949220640

Access comprehensive regulatory information for Buccal Tubes 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 06936949220640 and manufactured by Innovative Material and Devices, Inc in China.

This page provides complete registration details including trade name (Buccal Tubes), 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
06936949220640
No
Buccal Tubes
Trade Name: Buccal Tubes
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Device Description (EMDN)

ORTHODONTIC BRACKETS AND BUTTONS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q010403
Trade Name
Buccal Tubes
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06936949220640
Basic UDI
693694926636-74003P
Version Date
April 27, 2023
Manufacturer Last Update
March 22, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
3F, Building #5, No. 615 Fengdeng Rd., Jiading District, Shanghai, China Shanghai
Email
wang.weina@imdmedical.com
Authorized Representative
SRN
NL-AR-000000121
Country
Netherlands
Address
Koningin Julianaplein 10, 1e Verd The Hague
Email
peter@lotusnl.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:2023-04-06~2023-04-12, Italy:2023-04-12~2023-04-15
Device Characteristics
Human Tissues
No
Animal Tissues
No