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Lingual Buttons - EUDAMED Registration 06923733200247

Access comprehensive regulatory information for Lingual Buttons 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 06923733200247 and manufactured by Zhejiang Yo Medical Technology Co., 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
06923733200247
No
Lingual Buttons
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
06923733200247
Basic UDI
69237332YOTCK0001R7
Version Date
May 29, 2024
Manufacturer Last Update
March 18, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
5th Floor, Building 1, No. 2 Lemin Road, Xinshi Town, Deqing, Huzhou, Zhejiang Province
Email
xs_hunter@126.com
Authorized Representative
SRN
NL-AR-000000247
Country
Netherlands
Address
Fascinatio Boulevard 522, Unit 1.7 Capelle aan den IJssel
Email
ec.rep@sungoglobal.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
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No