BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    seal rite valve

    Reg #: 3003902679 · FEI: 3003902679 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ENTER MEDICAL CORPORATION
    Registration Number
    3003902679
    FEI Number
    3003902679
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 66-5, Yao Tzu Chu, Tsai Kung Village, Hsin Kang Township
    City
    Chiayi County
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K152521

    Owner / Operator

    Firm Name
    ENTER MEDICAL CORPORATION
    Operator Number
    9054547
    Address
    No.66-5,Yao Tzu Chu, Tsai Kung Village, Hsin Kang Township
    City
    Chiayi County
    State
    TW-CYQ
    Postal Code
    61642
    Country
    TW
    Correspondent
    TSUNG FU KUO

    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
    Valve, Non-Rebreathing CBP

    Proprietary Names

    seal rite valve

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device