Philippines FDA registration IVDR-00328
Xpert® HCV Viral Load
Device information
- Product Name
- Xpert® HCV Viral Load
- Registration Number
- IVDR-00328
Manufacturer details
- Country of Origin
- Sweden
Importer & distribution
- Importer/Distributor
- Macare Medicals, Inc.
Registration dates
- Issuance Date
- January 22, 2025
- Expiry Date
- June 13, 2029
About this record
Access comprehensive regulatory information for Xpert® HCV Viral Load in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00328 and manufactured by Cepheid AB Röntgenvägen, 5, SE-171 54 Solna, Sweden in Sweden. The device was registered on January 22, 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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