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WL Check SARS-CoV-2 Ag Selftesting - ARCSA Registration f8f00e2801ca3c596135db0e548f4101

Access comprehensive regulatory information for WL Check SARS-CoV-2 Ag Selftesting in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID f8f00e2801ca3c596135db0e548f4101 and manufactured by WIENER LABORATORIES S.A.I.C. The device was registered on October 26, 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
f8f00e2801ca3c596135db0e548f4101
WL Check SARS-CoV-2 Ag Selftesting
ARCSA ID: f8f00e2801ca3c596135db0e548f4101
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
Wiener lab.
Commercial Name
65454 -SARS-COV-2 antigen IVD, kit,rapid ICT, self-testing
Sterilization Method
INMUNOANALISIS
Registration Information
Analysis ID
f8f00e2801ca3c596135db0e548f4101
Registration Date
October 26, 2022
Expiration Date
October 26, 2027
Creation Date
October 26, 2022
Product Use

RAPID TEST FOR SELF-ASSESSMENT OF THE PRESENCE OF SARS-COV-2 VIRUS ANTIGENS IN NASAL SWAB SAMPLES. THE RESULT OF THIS TEST IS INDICATIVE WITHOUT CONCLUSIVE DIAGNOSTIC VALUE.

Manufacturer
City
SANTA FE
Country
ARGENTINA
Address
MAIPU Nยฐ2571, ROSARIO, PROVINCE OF SANTA FE โ€“ ARGENTINA
Product Owner
Name
WIENER LABORATORIES S.A.I.C
Country
ARGENTINA
Authorized Representative
Address
MARISCAL SUCRE STREET: AV RIO AMAZONAS NUMBER: E4-69INTERSECTION: N19 AV PATRIA
Phone
22562680