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Electrocardiograph - EUDAMED Registration 06974297655035

Access comprehensive regulatory information for Electrocardiograph in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06974297655035 and manufactured by Guangzhou 3RAY Electronics 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 IIa
06974297655035
Yes
Electrocardiograph
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

GENERAL PURPOSE ELECTROCARDIOGRAPHS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12050301
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06974297655035
Basic UDI
697429765ECGVD
Version Date
October 23, 2024
Manufacturer Last Update
September 07, 2022
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
No.260 4F C-3 Bldg. Longshan Industry Park No.260 Yinglong Road, Longdong Tianhe District Guangzhou
Email
info@3ray.net.cn
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
France
Market Available
France:2024-01-01~2028-01-01
Device Characteristics
Human Tissues
No
Animal Tissues
No