BEUDAMED
    1,932 results · 21ms · 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 ×

    CMC HYGEA LTD

    Device
    EU MDR · Eu Md Class 1 ·CMC HYGEA LTD·On the market

    Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Reagent - 3 x 28 ml For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·January 3, 2018

    Multichem P, Part Code 08P90-10

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023

    Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023

    Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·October 18, 2023

    Aerogen Ltd

    Manufacturer
    🇮🇪 Ireland·5 Basic UDI-DIs·5 Devices·National Standards Authority of Ireland (NSAI)

    Medifill Ltd

    Manufacturer
    🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·National Standards Authority of Ireland (NSAI)

    Incereb Ltd

    Manufacturer
    🇮🇪 Ireland·4 Basic UDI-DIs·6 Devices

    DentalOrganiser Ltd

    Manufacturer
    🇮🇪 Ireland

    phenox Ltd

    Manufacturer
    🇮🇪 Ireland

    Palliare Ltd

    Manufacturer
    🇮🇪 Ireland

    Rottapharm Ltd

    Manufacturer
    🇮🇪 Ireland·18 Basic UDI-DIs·18 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    Ovelle Ltd

    Manufacturer
    🇮🇪 Ireland

    Vasorum Ltd.

    Manufacturer
    🇮🇪 Ireland

    Perfuze Ltd

    Manufacturer
    🇮🇪 Ireland

    Teleatherapy Ltd

    Manufacturer
    🇮🇪 Ireland·1 Basic UDI-DI·1 Device

    HiberGene Diagnostics Ltd

    Manufacturer
    🇮🇪 Ireland

    Class Medical Ltd.

    Manufacturer
    🇮🇪 Ireland·1 Basic UDI-DI·1 Device

    DMC Medical Ltd

    Manufacturer
    🇮🇪 Ireland

    Rehan Electronics Ltd

    Manufacturer
    🇮🇪 Ireland