BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PuraStat

    Reg #: 3010481555 · FEI: 3010481555 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FUSO PHARMACEUTICAL
    Registration Number
    3010481555
    FEI Number
    3010481555
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2-3-11 Morinomiya
    City
    Joto-ku Osaka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K242250

    Owner / Operator

    Firm Name
    Fuso Pharmaceutical
    Operator Number
    10092671
    Address
    2-3-11 Morinomiya
    City
    Joto-ku
    State
    Osaka
    Postal Code
    536-8523
    Country
    JP
    Correspondent
    Keijiro Mushiake

    US Agent

    Business Name
    3D-Matrix
    Contact Name
    Alan Miskewicz
    Address
    1234 Chestnut St Ste 205
    City
    Newton
    State
    MA
    ZIP
    02464
    Country
    US
    Email
    [email protected]
    Phone
    781 3739020

    Products

    Device Name Product Code
    Hemostatic Device For Endoscopic Gastrointestinal Use QAU

    Proprietary Names

    PuraStat

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)