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COBAS® ELECSYS PreciControl Syphilis - FDA Registration IVDR-00362B

Access comprehensive regulatory information for COBAS® ELECSYS PreciControl Syphilis in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00362B and manufactured by Roche Diagnostics GmbH - Sandhofer Strasse 116 68305 Mannheim Germany in Germany. The device was registered on May 21, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Roche (Philippines) Inc.), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.

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IVDR-00362B
COBAS® ELECSYS PreciControl Syphilis
Registered medical device in Philippines
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Device Information
Product Name
COBAS® ELECSYS PreciControl Syphilis
Registration Number
IVDR-00362B
Manufacturer Details
Importer & Distribution
Importer/Distributor
Roche (Philippines) Inc.
Registration Dates
Issuance Date
May 21, 2025
Expiry Date
January 09, 2030