Philippines FDA registration IVDR-00941

Xpert® HIV-1 Viral Load XC

Philippines flagPhilippines·Cepheid AB - Rontgenvagen 5, SE-171 54, Solna, Sweden·Sweden·Issued March 20, 2025 – March 20, 2026
Device information
Product Name
Xpert® HIV-1 Viral Load XC
Registration Number
IVDR-00941
Manufacturer details
Country of Origin
Sweden
Importer & distribution
Importer/Distributor
Macare Medicals, Inc.
Registration dates
Issuance Date
March 20, 2025
Expiry Date
March 20, 2026
About this record

Access comprehensive regulatory information for Xpert® HIV-1 Viral Load XC in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00941 and manufactured by Cepheid AB - Rontgenvagen 5, SE-171 54, Solna, Sweden in Sweden. The device was registered on March 20, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Macare Medicals, 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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