BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PuraStat

    Reg #: 3002807408 · FEI: 3002807408 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KOGA ISOTOPE LTD.
    Registration Number
    3002807408
    FEI Number
    3002807408
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    53-6 Jinbo,Koka-cho
    City
    Koka-shi Shiga
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K242250

    Owner / Operator

    Firm Name
    KOGA ISOTOPE LTD.
    Operator Number
    10025197
    Address
    53-6 Jinbo,Koka-cho
    City
    Koka-shi
    State
    Shiga
    Postal Code
    520-3404
    Country
    JP

    US Agent

    Business Name
    Center for Regulatory Services, Inc.
    Contact Name
    Kristi Smedley
    Address
    1536 Canoe House Rd
    City
    Jamaica
    State
    VA
    ZIP
    23079
    Country
    US
    Email
    [email protected]
    Phone
    703 7867674

    Products

    Device Name Product Code
    Hemostatic Device For Endoscopic Gastrointestinal Use QAU

    Proprietary Names

    PuraStat

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)