Pure Global

Fetal Monitor - ARCSA Registration d7f4a633bac97e5685b71259c7734443

Access comprehensive regulatory information for Fetal Monitor in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID d7f4a633bac97e5685b71259c7734443 and manufactured by EDAN INSTRUMENTS, INC.. The device was registered on December 02, 2022.

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.

Free Database
Powered by Pure Global AI
ARCSA Official Data
III
d7f4a633bac97e5685b71259c7734443
Fetal Monitor
ARCSA ID: d7f4a633bac97e5685b71259c7734443
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Classification
Risk Class
III
Product Type
Active
Brand Name
WACKY
Commercial Name
Monitoring Systems, Physiological
Sterilization Method
NOT APPLICABLE
Registration Information
Analysis ID
d7f4a633bac97e5685b71259c7734443
Registration Date
December 02, 2022
Expiration Date
December 02, 2027
Creation Date
February 12, 2022
Product Use

TO MONITOR FETAL HEART RATE (FHR), TWIN FHR, TOUCH, FETAL MOVEMENT (FM), AUTOMATIC FETAL MOVEMENT (AFM), AND STIMULATION FETAL CONTINUOUSLY.

Manufacturer
City
SHENZEN
Country
CHINA
Address
N. 15 JINHUI ROAD, JINSHA COMMUNITY, KENGZI SUB-DISTRICT PINGSHAN DISTRICT, 518122 SHENZEN, PEOPLE'S REPUBLIC OF CHINA
Product Owner
Name
EDAN INSTRUMENTS, INC.
Country
CHINA
Authorized Representative
Address
LUIS MORENO MORA AND FRANCISCO MOSCOSO
Phone
2818889