BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QRS12

    Reg #: 1066427 · FEI: 3007513035 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INFINIUM MEDICAL, INC.
    Registration Number
    1066427
    FEI Number
    3007513035
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12151 62ND ST., N,, UNIT 5
    City
    Largo
    State
    FL
    ZIP
    33773
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113485

    Owner / Operator

    Firm Name
    INFINIUM MEDICAL, INC.
    Operator Number
    10028895
    Address
    12151 62ND ST N, UNIT 5
    City
    Largo
    State
    FL
    Postal Code
    33773
    Country
    US
    Correspondent
    Oz Ozkaya

    Products

    Device Name Product Code
    Electrocardiograph DPS

    Proprietary Names

    QRS12

    Establishment Types

    Repack or Relabel Medical Device