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Intraoral Scanner - EUDAMED Registration 06970163083094

Access comprehensive regulatory information for Intraoral Scanner 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 06970163083094 and manufactured by Shining 3D Tech Co., Ltd. in China.

This page provides complete registration details including trade name (Atip 3S), 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
06970163083094
Yes
Intraoral Scanner
Trade Name: Atip 3S
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Device Description (EMDN)

ODONTOLOGY DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q0199
Trade Name
Atip 3S
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06970163083094
Basic UDI
697016308AoralscanP8
Active Status
Yes
Manufacturer
Manufacturer Name
Shining 3D Tech Co., Ltd.
Country
China
Country Type
NON_EU
Address
No.1398, Xiangbin Road,Wenyan, Xiaoshan, Hangzhou, Zhejiang. China. Hangzhou
Email
sales@shining3d.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
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Netherlands
Market Available
Germany:None~None, Netherlands:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No