BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIO- IN01, Infusion sets, 20 Drops per minute

    Reg #: 3010830834 · FEI: 3004525092 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BiometerPlus USA, Inc.
    Registration Number
    3010830834
    FEI Number
    3004525092
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    48531 Warm Springs Blvd., #416
    City
    Fremont
    State
    CA
    ZIP
    94539
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191640

    Owner / Operator

    Firm Name
    BiometerPlus USA, Inc.
    Operator Number
    10046647
    Address
    48531 Warm Springs Blvd., #416
    City
    Fremont
    State
    CA
    Postal Code
    94539
    Country
    US
    Correspondent
    Jian Zhou

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA

    Proprietary Names

    BIO- IN01, Infusion sets, 20 Drops per minute BIO- IN02, Infusion sets, 60 Drops per minute

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility