BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COGENTIX MEDICAL, INC.

    Reg #: 1223490 · FEI: 1000136543 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    COGENTIX MEDICAL, INC.
    Registration Number
    1223490
    FEI Number
    1000136543
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    135 Flanders Rd
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071127

    Owner / Operator

    Firm Name
    COGENTIX MEDICAL, INC.
    Operator Number
    9006902
    Address
    135 Flanders Road, --
    City
    Westborough
    State
    MA
    Postal Code
    01581
    Country
    US
    Correspondent
    Nicole - Boser

    Products

    Device Name Product Code
    Device, Cystometric, Hydraulic FEN
    Hysteroscope (And Accessories) HIH
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Image, Illumination, Fiberoptic, For Endoscope FFS

    Proprietary Names

    Catheter for Use with Urodynamics System ENT EndoSheath Technology CST-5000 Videocystoscope EndoSheath Technology

    Establishment Types

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