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Cobas HEV - 192 - ARCSA Registration 5a121d377cf3a40d7935f14fe0ad5a84

Access comprehensive regulatory information for Cobas HEV - 192 in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 5a121d377cf3a40d7935f14fe0ad5a84 and manufactured by ROCHE MOLECULAR SYSTEMS INC.. The device was registered on November 27, 2023.

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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III
5a121d377cf3a40d7935f14fe0ad5a84
Cobas HEV - 192
ARCSA ID: 5a121d377cf3a40d7935f14fe0ad5a84
Local name: cobas HEV - 192
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Device Classification
Risk Class
III
Product Type
In Vitro Diagnostic
Brand Name
ROCHE
Commercial Name
19-242 IVD Reagents/Kits, Molecular Assay, Infection, Viruses
Registration Information
Analysis ID
5a121d377cf3a40d7935f14fe0ad5a84
Registration Date
November 27, 2023
Expiration Date
November 27, 2028
Product Use

QUALITATIVE IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE DIRECT DETECTION OF HEPATITIS E VIRUS (HEV) RNA (GENOTYPES 1-4) IN HUMAN PLASMA

Manufacturer
City
BRANCHBURG
Country
UNITED STATES
Address
1080 US HIGHWAY 202 SOUTH, BRANCHBURG NEW JERSEY, 08876
Product Owner
Name
ROCHE DIAGNOSTICS GMBH
Country
GERMANY
Authorized Representative
Address
AV SIMON BOLIVAR N/A Y VIA A NAYON
Phone
3997100