BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ABL80 CO-OX

    Reg #: 2027541 · FEI: 2027541 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SENDX MEDICAL, INC.
    Registration Number
    2027541
    FEI Number
    2027541
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1945 PALOMAR OAKS WAY
    City
    CARLSBAD
    State
    CA
    ZIP
    92011
    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