BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Flexi-Seal® SIGNAL™ Fecal Management System

    Reg #: 8022978 · FEI: 3006582718 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FORTUNE MEDICAL INSTRUMENT CORP.
    Registration Number
    8022978
    FEI Number
    3006582718
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 256, Changchun 2nd Rd., Jhongli Dist.
    City
    Taoyuan City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K112342

    Owner / Operator

    Firm Name
    FORTUNE MEDICAL INSTRUMENT CORP.
    Operator Number
    8022978
    Address
    6 F., No. 29, Sec. 2, Jhongjheng E. Rd.,, Danshuei Dist,
    City
    New Taipei City
    State
    TW-TPE
    Postal Code
    251
    Country
    TW
    Correspondent
    ABE - WANG

    US Agent

    Business Name
    J & F Technology Service
    Contact Name
    Fanny Zhao
    Address
    19838 Moon Shadow Circle
    City
    Walnut
    State
    CA
    ZIP
    91789
    Country
    US
    Email
    [email protected]
    Phone
    909 5100201

    Products

    Device Name Product Code
    Tubes, Gastrointestinal (And Accessories) KNT

    Proprietary Names

    Flexi-Seal® SIGNAL™ Fecal Management System Flexi-Seal Signal FMS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)