BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter

    Reg #: 3022518300 · FEI: 3022518300 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    KHTP STERILISATION SERVICES SDN. BHD.
    Registration Number
    3022518300
    FEI Number
    3022518300
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot 33, Jalan Hi-Tech 4
    City
    Kulim Hi Tech Park Kedah
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K183461

    Owner / Operator

    Firm Name
    Khtp Sterilisation Services Sdn. Bhd.
    Operator Number
    10085005
    Address
    Lot 33, Jalan Hi-Tech 4
    City
    Kulim Hi Tech Park
    State
    Kedah
    Postal Code
    09090
    Country
    MY

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Catheter, Urethral GBM
    Catheter, Urological KOD

    Proprietary Names

    (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter Rusch Hydrophilic Intermittent catheters Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)