BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Bronchoscope (flexible or rigid)

    Reg #: 3038613760 · FEI: 3038613760 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GT2 HEALTHCARE SDN.BHD.
    Registration Number
    3038613760
    FEI Number
    3038613760
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot 5-3, Jalan Hi-Tech 6, Zon Industri Fasa 2, Kulim Hi-Tech Park
    City
    Kulim Kedah
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K173727

    Owner / Operator

    Firm Name
    GT2 HEALTHCARE SDN.BHD.
    Operator Number
    10093482
    Address
    Lot 5-3, Jalan Hi-Tech 6, Zon Industri Fasa 2, Kulim Hi-Tech Park
    City
    Kulim
    State
    Kedah
    Postal Code
    09000
    Country
    MY

    US Agent

    Business Name
    mdi Consultants, Inc.
    Contact Name
    Alan Schwartz
    Address
    55 Northern Blvd
    City
    Great Neck
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Bronchoscope (Flexible Or Rigid) EOQ

    Proprietary Names

    Bronchoscope (flexible or rigid)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)