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Mouth Tray - EUDAMED Registration 06970016620216

Access comprehensive regulatory information for Mouth Tray in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 06970016620216 and manufactured by Jiangxi Dentalbright 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 I
06970016620216
No
Mouth Tray
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

IMPRESSION MATERIAL TRAYS, SINGLE-USE

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q010503
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06970016620216
Basic UDI
697001662MouthTrayZ8
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Makou Industrial Park, Yongxiu County, Jiujiang City, Jiangxi Province
Email
justin@enjoywhite.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
Austria
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