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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: Ireland ×

    LDH

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    LDH

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    LDH

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·1 device

    LDH

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·1 device

    BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Ireland, Inc.·December 31, 2025

    Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·September 23, 2020