Pure Global AI
EUDAMED registration 06970016620339No

Gingival Barrier

Jiangxi Dentalbright Technology Co.,LtdClass IEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Q0199
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06970016620339
Basic UDI
697001662GingivalL5
Active status
No
Manufacturer
Manufacturer name
Jiangxi Dentalbright Technology Co.,Ltd
Country
China
Country type
NON_EU
Address
Makou Industrial Park, Yongxiu County, Jiujiang City, Jiangxi Province
Email
justin@enjoywhite.com
Authorized representative
Name
SUNGO Europe B.V.
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
Device description (EMDN)

ODONTOLOGY DEVICES - OTHER

About this record

Access comprehensive regulatory information for Gingival Barrier 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 06970016620339 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.