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AFIAS Covid-19/FLU Ag (combo) - ARCSA Registration 43d2e5eb1c707cfd7a4c366f1e1040aa

Access comprehensive regulatory information for AFIAS Covid-19/FLU Ag (combo) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 43d2e5eb1c707cfd7a4c366f1e1040aa and manufactured by BODITECH WITH INC.. The device was registered on August 02, 2022.

This page provides complete registration details including product type (In Vitro Diagnostic), 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
III
43d2e5eb1c707cfd7a4c366f1e1040aa
AFIAS Covid-19/FLU Ag (combo)
ARCSA ID: 43d2e5eb1c707cfd7a4c366f1e1040aa
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
Afias
Commercial Name
17-077 IVD Reagents/Testing Kits, Serology, Viruses
Registration Information
Analysis ID
43d2e5eb1c707cfd7a4c366f1e1040aa
Registration Date
August 02, 2022
Expiration Date
August 02, 2027
Product Use

SIMULTANEOUS DETERMINATION OF INFLUENZA A, B VIRUS AND / OR INFECTION BY SARS-COV-2 OR THE RESPECTIVE DETECTION OF EACH VIRUS IN NASOPHARYNGEAL SWAB

Manufacturer
City
CHUNCHEON, GANGWON-DO
Country
KOREA, REPUBLIC OF
Address
43, GEODUDANJI 1-GIL, DONGNAE-MYEON, CHUNCHEON-SI, GANGWON DO
Product Owner
Name
BODITECH WITH INC.
Country
KOREA, REPUBLIC OF
Authorized Representative
Address
NEIGHBORHOOD: COOP DE VIVIENDA SERVIDORES Y MANZANA:21 CALLE:AVENIDA JUANTANCA MARENGO, SOLAR 5 INTERSECTION: SN
Phone
42233672