BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    CompactCath

    Reg #: 3014498861 · FEI: 3014498861 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ATOM HEALTH CORPORATION
    Registration Number
    3014498861
    FEI Number
    3014498861
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1F., No. 29, Minsheng 6th St., Guiren Dist.,
    City
    Tainan City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K180738

    Owner / Operator

    Firm Name
    ATOMHEALTH Corporation
    Operator Number
    10057545
    Address
    4FL.-3, No.112, Sec.2, Zhongshan North Road
    City
    Zhongshan Dist., Taipei City
    State
    TW-TPE
    Postal Code
    104
    Country
    TW

    Products

    Device Name Product Code
    Catheter, Straight EZD
    Catheter, Coude EZC

    Proprietary Names

    CompactCath

    Establishment Types

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