BEUDAMED
    31 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 ×

    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)

    Syncrophi Systems Ltd

    Manufacturer
    🇮🇪 Ireland·1 Basic UDI-DI·1 Device·National Standards Authority of Ireland (NSAI)

    ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Abbott Ireland Diagnostics Division·December 3, 2014

    CutisSeal Topical B

    Device
    EU MDD · Eu Md Class 2a ·Medifill Ltd·On the market·1 country

    CutisSeal Topical H

    Device
    EU MDD · Eu Md Class 2a ·Medifill Ltd·On the market·1 country

    KEWS300

    Device
    EU MDD · Eu Md Class 2b ·Syncrophi Systems Ltd·On the market·1 country

    Aerogen USB Controller

    Device
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·7 countries

    Aerogen USB Controller

    Device
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·1 country

    Aerogen Ultra (10 Pack)

    Device
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·1 country

    Aerogen Solo Adult T-Piece 22mm

    Device
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·13 countries

    Aerogen Solo Nebuliser (10 Pack)

    Device
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·On the market·25 countries

    KEWS300

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·Syncrophi Systems Ltd·1 device

    CutisSeal Topical B

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Medifill Ltd·1 device

    CutisSeal Topical H

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Medifill Ltd·1 device

    AG-AS3200

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·1 device

    AG-AS3010

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·1 device

    AG-UC1000-NE

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·1 device

    AG-UC1000-IN

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·1 device

    AG-AS7000-EU

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Aerogen Ltd·1 device