BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    GENEXPERT DX SYSTEM

    Reg #: 3007923088 · FEI: 3007923088 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sanmina-SCI Systems (Malaysia) Sdn Bhd
    Registration Number
    3007923088
    FEI Number
    3007923088
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    202 Lorong Perushaan Maju 9, Bukit Tengah Industrial Park
    City
    Perai Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K212213

    Owner / Operator

    Firm Name
    Sanmina Corporation
    Operator Number
    2129538
    Address
    13000 S. Memorial Pkwy, --
    City
    Huntsville
    State
    AL
    Postal Code
    35803
    Country
    US

    US Agent

    Business Name
    Sanmina Corporation
    Contact Name
    Jeffrey Stahl
    Address
    13000 S Memorial Pkwy
    City
    Huntsville
    State
    AL
    ZIP
    35803
    Country
    US
    Email
    [email protected]
    Phone
    256 4794797

    Products

    Device Name Product Code
    Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System PQA
    Instrumentation For Clinical Multiplex Test Systems NSU

    Proprietary Names

    GENEXPERT DX SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)