BEUDAMED
    2 results · 18ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs

    FDA Enforcement
    Class II ·Terminated·Church & Dwight Inc·July 31, 2013

    Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·February 5, 2020