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    FDA Registration Active 🇲🇾 Malaysia

    Ambu10292 (PK) - Neuroline Concentric Needle Electrode (740)

    Reg #: 3008252486 · FEI: 3008252486 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ELECTRON BEAM SDN BHD
    Registration Number
    3008252486
    FEI Number
    3008252486
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot 7 Jalan Sungai Pinang 4/3, Pulau Indah Industrial Park Phase 2
    City
    Port Klang Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K071186

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10042227
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    US Agent

    Business Name
    STERIS Corporation
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 4687462

    Products

    Device Name Product Code
    Electrode, Needle, Diagnostic Electromyograph IKT

    Proprietary Names

    Ambu10292 (PK) - Neuroline Concentric Needle Electrode (740)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)