BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Flexible Overtube

    Reg #: 1000163068 · FEI: 1000163068 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SB-KAWASUMI LABORATORIES, INC.
    Registration Number
    1000163068
    FEI Number
    1000163068
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-25-4 Tonomachi,, Kawasaki-ku
    City
    Kawasaki-shi Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K182520

    Owner / Operator

    Firm Name
    SB-KAWASUMI LABORATORIES, INC.
    Operator Number
    8031539
    Address
    3-25-4 Tonomachi, Kawasaki-ku
    City
    Kawasaki-shi
    State
    Kanagawa
    Postal Code
    210-8602
    Country
    JP
    Correspondent
    Kenichi - Inamura

    US Agent

    Business Name
    MIC International
    Contact Name
    Deno Zachary
    Address
    201 East 69th Street, Suite 5O,
    City
    New York
    State
    NY
    ZIP
    10021
    Country
    US
    Email
    [email protected]
    Phone
    917 3315789

    Products

    Device Name Product Code
    Endoscopic Access Overtube, Gastroenterology-Urology FED

    Proprietary Names

    Flexible Overtube

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility