BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ABL80 CO-OX

    Reg #: 3014506106 · FEI: 3014506106 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Radiometer Minneapolis
    Registration Number
    3014506106
    FEI Number
    3014506106
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    121 5th Avenue W
    City
    New Brighton
    State
    MN
    ZIP
    55112
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151639

    Owner / Operator

    Firm Name
    RADIOMETER MEDICAL APS
    Operator Number
    8020503
    Address
    AAKANDEVEJ 21, --
    City
    BROENSHOEJ
    State
    Hovedstaden
    Postal Code
    2700
    Country
    DK
    Correspondent
    Hsiao-Qing Chow

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA

    Proprietary Names

    ABL80 CO-OX ABL80 FLEX

    Establishment Types

    Manufacture Medical Device