BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    i-STAT Portable Clinical Analyzer

    Reg #: 3003589956 · FEI: 3003589956 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Flextronics Manufacturing (Singapore) Pte Ltd
    Registration Number
    3003589956
    FEI Number
    3003589956
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Kallang Place
    City
    SINGAPORE South East
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K001387

    Owner / Operator

    Firm Name
    Flextronics International USA, Inc.
    Operator Number
    9006592
    Address
    6201 America Center Drive
    City
    San Jose
    State
    CA
    Postal Code
    95002
    Country
    US
    Correspondent
    Chad Ashton

    US Agent

    Business Name
    FLEXTRONICS INTERNATIONAL USA, INC.
    Contact Name
    Chad Ashton
    Address
    12455 Research Blvd
    City
    Austin
    State
    TX
    ZIP
    78759
    Country
    US
    Email
    [email protected]
    Phone
    901 8712423

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA

    Proprietary Names

    i-STAT Portable Clinical Analyzer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)