BIOR FLEX 01 BS BLOOD FILTER - FDA Registration MDR-07586

Access comprehensive regulatory information for BIOR FLEX 01 BS BLOOD FILTER in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-07586 and manufactured by Fresenius Kabi Asia Pacific, Ltd. - Room 5001-5027, 50th Floor Sun Hung Kai Centre, 30 Harbour Road, Wanchai, Hong Kong mfd. by: Fresenius HemoCare Italia S.r.l. - Via San Pietro 1, 41037 Mirandola, Italy For Fresenius Kabi AG - Else-Kröner-Str. 1, 61352 Bad Homburg, Germany in Germany. The device was registered on April 23, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Fresenius Kabi 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.