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Elecsys Active B12 - ARCSA Registration 0f7e96ac61c8acfacaf084770fafb838

Access comprehensive regulatory information for Elecsys Active B12 in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 0f7e96ac61c8acfacaf084770fafb838 and manufactured by ROCHE DIAGNOSTICS GMBH. The device was registered on August 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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ARCSA Official Data
II
0f7e96ac61c8acfacaf084770fafb838
Elecsys Active B12
ARCSA ID: 0f7e96ac61c8acfacaf084770fafb838
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Device Classification
Risk Class
II
Product Type
In Vitro Diagnostic
Brand Name
COBAS
Commercial Name
19-141 IVD Test Reagent/Kits, Immunoassay, Vitamin, B12 (Cyanocobalamin)
Registration Information
Analysis ID
0f7e96ac61c8acfacaf084770fafb838
Registration Date
August 27, 2023
Expiration Date
August 27, 2028
Product Use

QUANTITATIVE DETERMINATION OF ACTIVE VITAMIN B12 (HOLOTRANSCOBALAMIN) IN HUMAN SERUM.

Manufacturer
City
MANNHEIM
Country
GERMANY
Address
SANDHOFER STR. 116, 68305 MANNHEIM
Product Owner
Name
ROCHE DIAGNOSTICS GMBH
Country
GERMANY
Authorized Representative
Address
AV SIMON BOLIVAR N/A Y VIA A NAYON
Phone
3997100