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d41e83a1dbe4305807bdfca967d54672

CKMB

ROCHE DIAGNOSTICS GMBH·III·Ecuador ARCSA·Registered August 10, 2023
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
COBAS
Commercial name
19-092 IVD Assay Reagents/Kits, Immunoassay, Cardiac Marker
Registration information
Analysis ID
d41e83a1dbe4305807bdfca967d54672
Registration date
August 10, 2023
Expiration date
August 10, 2028
Manufacturer
Name
ROCHE DIAGNOSTICS GMBH
City
MANNHEIM
Country
GERMANY
Address
SANDHOFER STR. 116, 68305 MANNHEIM
Product owner
Name
ROCHE DIAGNOSTICS GMBH
Country
GERMANY
Authorized representative
Name
ROCHE ECUADOR S.A.
Address
AV SIMON BOLIVAR N/A Y VIA A NAYON
Phone
3997100
Product use

QUANTITATIVE DETERMINATION OF THE CATALYTIC ACTIVITY OF THE CREATINE KINASE MB SUBUNIT (CK-MB) IN HUMAN SERUM AND PLASMA.

About this record

Access comprehensive regulatory information for CKMB in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID d41e83a1dbe4305807bdfca967d54672 and manufactured by ROCHE DIAGNOSTICS GMBH. The device was registered on August 10, 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.