BEUDAMED
    FDA Registration Active 🇨🇳 China

    Over-Tube TS-1314B

    Reg #: 3004052101 · FEI: 3004052101 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Dalian Create Medical Products Co., LTD.
    Registration Number
    3004052101
    FEI Number
    3004052101
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. IIB-31, Dalian Export Processing Zone
    City
    Dalian Liaoning
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K223295

    Owner / Operator

    Firm Name
    FUJIFILM CORPORATION
    Operator Number
    8031568
    Address
    26-30, Nishiazabu 2-chome
    City
    MINATO-KU
    State
    Tokyo
    Postal Code
    106-8620
    Country
    JP
    Correspondent
    Randy Vader

    US Agent

    Business Name
    FUJIFILM Healthcare Americas Corporation
    Contact Name
    Randy Vader
    Address
    81 Hartwell Avenue, Suite 300
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US
    Email
    [email protected]
    Phone
    360 3566821

    Products

    Device Name Product Code
    Colonoscope And Accessories, Flexible/Rigid FDF
    Enteroscope And Accessories FDA

    Proprietary Names

    Over-Tube TS-1314B Endoscope Model EN-580T Tube Kit TY-500D Scope Balloon BS-4

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)