BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    BiWaze Clear System

    Reg #: 3009987158 · FEI: 3009987158 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AMT PTE. LTD.
    Registration Number
    3009987158
    FEI Number
    3009987158
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 Tuas Lane
    City
    Singapore South West
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K231728

    Owner / Operator

    Firm Name
    AMT PTE. LTD.
    Operator Number
    10079864
    Address
    3 Tuas Lane
    City
    Singapore
    State
    South West
    Postal Code
    638612
    Country
    SG

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Device, Positive Pressure Breathing, Intermittent NHJ

    Proprietary Names

    BiWaze Clear System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)