BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IUI-M Intra Uterine Insemination Catheter with Malleable Stylet

    Reg #: 3005987240 · FEI: 3005987240 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ALLWIN MEDICAL DEVICES, INC.
    Registration Number
    3005987240
    FEI Number
    3005987240
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3305 E. MIRALOMA AVENUE, SUITE 176
    City
    ANAHEIM
    State
    CA
    ZIP
    92806
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190522

    Owner / Operator

    Firm Name
    ALLWIN MEDICAL DEVICES, INC.
    Operator Number
    9094082
    Address
    3305 E. Miraloma Ave, SUITE 176
    City
    Anaheim
    State
    CA
    Postal Code
    92806
    Country
    US
    Correspondent
    Digish D Mehta

    Products

    Device Name Product Code
    Cannula, Intrauterine Insemination MFD
    Catheter, Assisted Reproduction MQF

    Proprietary Names

    IUI-M Intra Uterine Insemination Catheter with Malleable Stylet FLEXI Intra Uterine Insemination Catheter TRACKABLE Intra Uterine Insemination Catheter Open Tip with Malleable Stylet CURVED Intra Uterine Insemination Catheter Open Tip Curved FLEXI Intra Uterine Insemination Catheter Open Tip INSEMINA Intra Uterine Insemination Catheter CURVED Intra Uterine Insemination Catheter Curved INSEMINA Intra Uterine Insemination Catheter Open Tip STUMPY Intra Uterine Insemination Cannula TRACKABLE Intra Uterine Insemination Catheter with Malleable Stylet IUI-C Intra Uterine Insemination Catheter Curved IUI SHORTY Intra Uterine Insemination Cannula Shorty INTEGRA Intra Uterine Insemination Catheter

    Establishment Types

    Manufacture Medical Device