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28fdb65e265165e76d8049436123f9e7

CPAP BABYPAP

FANEM LTDA·III·Ecuador ARCSA·Registered December 02, 2022
Device classification
Risk class
III
Product type
Active
Brand name
FAN, BABYPAP, FOG
Commercial name
VENTILATORS, INTENSIVE CARE, NEONATAL/PEDIATRIC
Sterilization method
NON-STERILE
Registration information
Analysis ID
28fdb65e265165e76d8049436123f9e7
Registration date
December 02, 2022
Expiration date
December 02, 2027
Creation date
February 12, 2022
Manufacturer
Name
FANEM LTDA
City
SAO PAULO
Country
BRAZIL
Address
STREET ARTHUR CARL SCHMIDT 186 - CUMBICA - GUARULHOS, SP CEP:07222-050
Product owner
Name
FANEM LTDA
Country
BRAZIL
Authorized representative
Name
INGEMEDICA DEL ECUADOR S.A.
Address
AV. JUAN TANCA MARENGO AND AV. GUILLERMO CUBILLA
Phone
42594500
Product use

IT IS A NASAL BUBBLE CPAP EQUIPMENT DEVELOPED FOR USE IN NEONATAL NON-INVASIVE VENTILATORY ASSISTANCE, AND HAS BEEN APPLIED, ESPECIALLY, IN PREMATURE NEWBORNS WITH RESPIRATORY DISCOMFORT OF PULMONARY CAUSE AND WITH SPONTANEOUS BREATHING.

About this record

Access comprehensive regulatory information for CPAP BABYPAP in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 28fdb65e265165e76d8049436123f9e7 and manufactured by FANEM LTDA. 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.