BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    VentiSure2

    Reg #: 3011503227 · FEI: 3011503227 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Intersurgical Medical Sdn. Bhd.
    Registration Number
    3011503227
    FEI Number
    3011503227
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    993,Lorong Perindustrian Bukit Minyak 11, Taman Perindustrian Bukit Minyak
    City
    Simpang Ampat Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K924610

    Owner / Operator

    Firm Name
    ENGINEERED MEDICAL SYSTEMS
    Operator Number
    9022693
    Address
    2055 EXECUTIVE DR., --
    City
    INDIANAPOLIS
    State
    IN
    Postal Code
    46241
    Country
    US
    Correspondent
    TAMARA - LEFEVERS

    US Agent

    Business Name
    ENGINEERED MEDICAL SYSTEMS
    Contact Name
    TAMARA Lefevers
    Address
    2055 Executive Dr
    City
    Indianapolis
    State
    IN
    ZIP
    46241
    Country
    US
    Email
    [email protected]
    Phone
    317 2465500

    Products

    Device Name Product Code
    Ventilator, Emergency, Manual (Resuscitator) BTM

    Proprietary Names

    VentiSure2 FENEM VT Select

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)