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Computed Tomography X-ray System - EUDAMED Registration 06971576831494

Access comprehensive regulatory information for Computed Tomography X-ray System 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 06971576831494 and manufactured by Shanghai United Imaging Healthcare Co.,Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), 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
06971576831494
Yes
Computed Tomography X-ray System
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Z11030607
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
06971576831494
Basic UDI
697157683149NP
Version Date
December 18, 2024
Manufacturer Last Update
December 20, 2023
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
2258 Chengbei Road, Jiading District Shanghai
Email
services@united-imaging.com
Authorized Representative
SRN
DE-AR-000000001
Country
Germany
Address
80 EiffestraรŸe Hamburg
Email
shholding@hotmail.com
Telephone
+49 40 2513175
Regulatory Information
Competent Authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Poland
Market Available
Poland:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No