BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    INNOLATEX SDN. BHD

    Reg #: 9616515 · FEI: 3003117682 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INNOLATEX SDN. BHD
    Registration Number
    9616515
    FEI Number
    3003117682
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT 591 & 594, PERSIARAN RAJA LUMU, PANDAMARAN INDUSTRIAL ESTATE,
    City
    PORT KLANG Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K091828

    Owner / Operator

    Firm Name
    INNOLATEX SDN. BHD
    Operator Number
    9042429
    Address
    LOT 591 & 594, PERSIARAN RAJA LUMU,, PANDAMARAN INDUSTRIAL ESTATE,
    City
    PORT KLANG
    State
    Selangor
    Postal Code
    42000
    Country
    MY
    Correspondent
    GOH MIAH KIAT

    US Agent

    Business Name
    Global Protection Corp.
    Contact Name
    Davin Wedel
    Address
    12 Channel Street
    City
    Boston
    State
    MA
    ZIP
    02210
    Country
    US
    Email
    [email protected]
    Phone
    617 9462800

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)