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    FDA Registration Active 🇲🇾 Malaysia

    EngineeredMed (KD) - Aero-Sat Filter Small Angled

    Reg #: 3010237023 · FEI: 3010237023 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Synergy Sterilisation Kulim (m) Sdn. Bhd.
    Registration Number
    3010237023
    FEI Number
    3010237023
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    71 Kulim Industrial Estate
    City
    Kulim Kedah
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K013089

    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
    Synergy Health
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Rd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 3927490

    Products

    Device Name Product Code
    Filter, Bacterial, Breathing-Circuit CAH

    Proprietary Names

    EngineeredMed (KD) - Aero-Sat Filter Small Angled EngineeredMed (KD) - Aero-Sat Mini Heat Moisture Exchanger EngineeredMed (KD) - Aero-Sat Filter Small Straight EngineeredMed (KD) - Aero-Pro Filter Small Angled Bacterial / Viral Depth Filter EngineeredMed (KD) - Aero-Pro Filter Small Straight Bacterial / Viral Depth Filter EngineeredMed (KD) - Aero-Sat 1 Straight Heat Moisture Exchanger EngineeredMed (KD) - Aero-Sat Micro+ 3 EngineeredMed (KD) - Aero-Sat Filter Compact Angled EngineeredMed (KD) - Aero-Sat Filter Compact Straight EngineeredMed (KD) - Aero-Sat 2 Angled Heat Moisture Exchanger EngineeredMed (KD) - Aero-Pro Filter Compact Straight Bacterial / Viral Depth Filter EngineeredMed (KD) - Aero-Sat Filter Pedi EngineeredMed (KD) - Aero-T EngineeredMed (KD) - Aero-Pro HEPA Small Angled EngineeredMed (KD) - Aero-Sat 2 Straight Heat Moisture Exchanger EngineeredMed (KD) - Aero-Pro S Filter Bacterial / Viral Depth Filter EngineeredMed (KD) - Aero-Pro Filter Compact Angled Bacterial / Viral Depth Filter EngineeredMed (KD) - Aero-Sat 1 Straight Heat Moisture Exchanger with Port EngineeredMed (KD) - Aero-Sat Micro+ 3.5 Heat Moisture Exchanger EngineeredMed (KD) - Aero-T+

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)