93c7cedc46cf7f45af9204ce8bdd6f14
HOLTER SYSTEM
Local name: SISTEMA HOLTER
EDAN INSTRUMENTS, INC.·II·Ecuador ARCSA·Registered December 22, 2023
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
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
Product use
ACQUIRE RESTING ECG SIGNALS FROM ADULT AND PEDIATRIC PATIENTS VIA BODY SURFACE ECG ELECTRODES.
About this record
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.