BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CST-5000 Videocystoscope

    Reg #: 2242464 · FEI: 2242464 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    COGENTIX MEDICAL, INC.
    Registration Number
    2242464
    FEI Number
    2242464
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    40 Ramland Rd S
    City
    ORANGEBURG
    State
    NY
    ZIP
    10962
    Country
    US

    Regulatory Submissions

    510(k) Number
    K072180

    Owner / Operator

    Firm Name
    COGENTIX MEDICAL, INC.
    Operator Number
    9105687
    Address
    40 RAMLAND RD. SOUTH, --
    City
    Orangeburg
    State
    NY
    Postal Code
    10962
    Country
    US
    Correspondent
    Nicole - Boser

    Products

    Device Name Product Code
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Image, Illumination, Fiberoptic, For Endoscope FFS
    Cystoscope And Accessories, Flexible/Rigid FAJ

    Proprietary Names

    CST-5000 Videocystoscope Digital Cystoscope and EndoSheath

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device