BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    EpiFaith CV

    Reg #: 3014716786 · FEI: 3014716786 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    FLAT MEDICAL CO., LTD.
    Registration Number
    3014716786
    FEI Number
    3014716786
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12F.-2, No. 206, Sec. 2, Nanjing E. Rd.,, Zhongshan Dist., Taipei 104496, Taiwan
    City
    Taipei
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K212615

    Owner / Operator

    Firm Name
    Flat Medical Co., Ltd.
    Operator Number
    10060448
    Address
    12.-2, No. 206, Sec. 2, Nanjing E. Rd.,, Zhongshan Dist., Taipei 104496, Taiwan
    City
    Taipei
    State
    TW-TPE
    Postal Code
    104496
    Country
    TW
    Correspondent
    Shao Wei Tseng

    US Agent

    Business Name
    SUN DESIGNE LTD. OF FLORIDA
    Contact Name
    Jack Taber
    Address
    SUN DESIGNE LTD. OF FLORIDA 241 N Sterling Road Sterling, CT US 06377
    City
    Sterling
    State
    CT
    ZIP
    06377
    Country
    US
    Email
    [email protected]
    Phone
    772 2887466

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    EpiFaith CV

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198