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Dental Cone-beam Computed Tomography - EUDAMED Registration 06975066322011

Access comprehensive regulatory information for Dental Cone-beam Computed Tomography in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 06975066322011 and manufactured by Hefei Meyer Optoelectronic Technology Inc. in China.

This page provides complete registration details including trade name (Dental Cone-beam Computed Tomography), manufacturer information, authorized representative details, competent authority (DE/CA304 - Marktรผberwachung Medizinprodukte Bayern), 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 IIb
06975066322011
Yes
Dental Cone-beam Computed Tomography
Trade Name: Dental Cone-beam Computed Tomography
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Device Description (EMDN)

COMPUTED TOMOGRAPHS (CT) - OTHER

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Z11030699
Trade Name
Dental Cone-beam Computed Tomography
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06975066322011
Basic UDI
697506632201UBX
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
No.668 Wangjiang West Road, High& New Tech. Industry Development Zone Hefei
Email
liutongshan@meyerop.com
Authorized Representative
SRN
DE-AR-000000087
Country
Germany
Address
8 Mies-van-der-Rohe-Strasse Munich
Email
info@medpath.pro
Telephone
+49 (0) 89 8130 6837
Regulatory Information
Competent Authority
DE/CA304 - Marktรผberwachung Medizinprodukte Bayern
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No