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Dynamic ECG Monitor - EUDAMED Registration 06973660370018

Access comprehensive regulatory information for Dynamic ECG Monitor 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 06973660370018 and manufactured by Suzhou Melodicare Medical Technology Co., Ltd. in China.

This page provides complete registration details including trade name (Mintti), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24), 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
06973660370018
Yes
Dynamic ECG Monitor
Trade Name: Mintti
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Device Description (EMDN)

ECG HOLTER RECORDERS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12050403
Trade Name
Mintti
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
06973660370018
Basic UDI
B-06973660370018
Version Date
April 13, 2022
Manufacturer Last Update
March 16, 2022
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
No.32 Hongxi Road Suzhou
Email
k.wang@mintti.cn
Authorized Representative
SRN
DE-AR-000005133
Country
Germany
Address
83 Heerdter Lohweg Dรผsseldorf
Email
eu-rep@share-info.com
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Poland
Market Available
France:2020-05-06~2025-05-27, Italy:2020-05-06~2025-05-27, Netherlands:2020-05-06~2025-05-27, Poland:2020-05-06~2025-05-27, United Kingdom (Northern Ireland only):2020-05-06~2025-05-27
Device Characteristics
Human Tissues
No
Animal Tissues
No