HOLTER SYSTEM - ARCSA Registration 93c7cedc46cf7f45af9204ce8bdd6f14
Access comprehensive regulatory information for HOLTER SYSTEM in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 93c7cedc46cf7f45af9204ce8bdd6f14 and manufactured by EDAN INSTRUMENTS, INC.. The device was registered on December 22, 2023.
This page provides complete registration details including product type (Active), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.
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ARCSA Official Data
II
93c7cedc46cf7f45af9204ce8bdd6f14
HOLTER SYSTEM
ARCSA ID: 93c7cedc46cf7f45af9204ce8bdd6f14
Local name: SISTEMA HOLTER
Device Classification
Risk Class
II
Product Type
Active
Brand Name
WACKY
Commercial Name
Electrocardiógrafos
Registration Information
Analysis ID
93c7cedc46cf7f45af9204ce8bdd6f14
Registration Date
December 22, 2023
Expiration Date
December 22, 2028
Product Use
ACQUIRE RESTING ECG SIGNALS FROM ADULT AND PEDIATRIC PATIENTS VIA BODY SURFACE ECG ELECTRODES.
Manufacturer
City
SHENZHEN
Country
CHINA
Address
NO. 15 JINHUI ROAD, JIHSHA COMMUNITY, KENGZI SUB-DISTRICT, PINGSHAN DISTRICT, SHENZHEN, 518122 P.R CHINA
Product Owner
Name
EDAN INSTRUMENTS, INC.
Country
CHINA
Authorized Representative
Address
IÑAQUITO / AV DE LOS SHYRIS N32218 AND AV ELOY ALFARO
Phone
25114587