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Fully Automatic Chemiluminescence Immunoassay Analyzer - EUDAMED Registration 06971792050099

Access comprehensive regulatory information for Fully Automatic Chemiluminescence Immunoassay Analyzer in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 06971792050099 and manufactured by Hangzhou Realy Tech Co.,Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (The Medicines and Healthcare Products Regulatory Agency), 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 A
06971792050099
No
Fully Automatic Chemiluminescence Immunoassay Analyzer
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0201020299
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06971792050099
Basic UDI
697179205CF7
Version Date
June 11, 2022
Manufacturer Last Update
May 21, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
#2 Building, No. 763, Yuansha Village, Xinjie Street, Xiaoshan District Hangzhou
Email
info@realytech.com
Authorized Representative
SRN
ES-AR-000019366
Country
Spain
Address
CALLE DE TAPIOLES, 33, 2- 1 Barcelona
Email
rep@themedunion.com
Telephone
+34644173535
Regulatory Information
Competent Authority
The Medicines and Healthcare Products Regulatory Agency
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Italy
Device Characteristics
Human Tissues
No
Animal Tissues
No