BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Two-way and Three-way Disposable Silicone Foley catheters

    Reg #: 3030970103 · FEI: 3030970103 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AP MDS CO.,LTD.
    Registration Number
    3030970103
    FEI Number
    3030970103
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    M-1804/3203, 32, Songdogwahak-ro, Yeonsu-gu
    City
    Incheon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K201776

    Owner / Operator

    Firm Name
    AP MDS Co.,Ltd.
    Operator Number
    10083007
    Address
    M-1804/3203, 32, Songdogwahak-ro, Yeonsu-gu
    City
    Incheon
    State
    KR-28
    Postal Code
    21984
    Country
    KR
    Correspondent
    Donghyuk Shin

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    Two-way and Three-way Disposable Silicone Foley catheters

    Establishment Types

    Manufacture Medical Device