BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDGYN PRODUCTS, INC.

    Reg #: 1450908 · FEI: 1450908 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    13
    Establishment Types
    4
    Classifications
    39

    Registration Details

    Registration Name
    MEDGYN PRODUCTS, INC.
    Registration Number
    1450908
    FEI Number
    1450908
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    800 Pasquinelli Dr
    City
    Westmont
    State
    IL
    ZIP
    60559
    Country
    US

    Regulatory Submissions

    510(k) Number
    K072210

    Owner / Operator

    Firm Name
    MEDGYN PRODUCTS, INC.
    Operator Number
    1450908
    Address
    800 Pasquinelli Dr., --
    City
    Westmont
    State
    IL
    Postal Code
    60559
    Country
    US
    Correspondent
    AMAR - AGADI

    Products

    Device Name Product Code
    Catheter, Balloon Type GBA
    Clamp, Umbilical HFW
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Tubing, Noninvasive GAZ
    Catheter, Assisted Reproduction MQF
    Colposcope (And Colpomicroscope) HEX
    Curette, Suction, Endometrial (And Accessories) HHK
    Apparatus, Exhaust, Surgical FYD
    Cannula, Manipulator/Injector, Uterine LKF
    Electrocautery, Gynecologic (And Accessories) HGI
    Brush, Biopsy, General & Plastic Surgery GEE
    Tube, Aspirating, Flexible, Connecting BYY
    Punch, Surgical LRY
    Needle, Assisted Reproduction MQE
    System, Monitoring, Perinatal HGM
    Bottle, Collection, Vacuum KDQ
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Monitor, Ultrasonic, Fetal KNG
    Speculum, Vaginal, Nonmetal HIB
    Sound, Uterine HHM
    Remover, Intrauterine Device, Contraceptive, Hook-Type HHF
    Dilator, Vaginal HDX
    Pessary, Vaginal HHW
    Guide, Needle, Surgical GDF
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Dilator, Cervical, Fixed Size HDQ
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Abortion, Vacuum HHI
    Spatula, Cervical, Cytological HHT
    Unit, Cryosurgical, Accessories GEH
    Amniotome HGE
    Dilator, Cervical, Hygroscopic-Laminaria HDY
    Speculum, Vaginal, Metal HDF
    Monitor, Heart Rate, Fetal, Ultrasonic HEL
    Cannula, Suction, Uterine HGH
    Source, Abortion Unit, Vacuum HGF
    Instrument, Manual, Surgical, General Use MDM
    Curette, Uterine HCY

    Proprietary Names

    Aspiration Hose Medgyn Smoke Evacuator AL-105 Inn Tec IUI Catheter HS Catheters Set Uterine Manipulator Morton IUI V-80 Vacuum Pump Synevac Vacuum Source Unit Laminaria Tent Synevac Vacuum Curettage Systems Disposable Mucous Sampler Utervac

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only