BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medegen Medical Products

    Reg #: 1043646 · FEI: 1043646 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    55
    Establishment Types
    5
    Classifications
    36

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    Registration Details

    Registration Name
    Medegen Medical Products
    Registration Number
    1043646
    FEI Number
    1043646
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    209 MEDEGEN DR.
    City
    GALLAWAY
    State
    TN
    ZIP
    38036
    Country
    US

    Regulatory Submissions

    510(k) Number
    K942054

    Owner / Operator

    Firm Name
    Medegen Medical Products
    Operator Number
    9005738
    Address
    209 MEDEGEN DR., --
    City
    Gallaway
    State
    TN
    Postal Code
    38036
    Country
    US

    Products

    Device Name Product Code
    Instrument, Surgical, Disposable KDC
    Douche Apparatus, Vaginal, Therapeutic HED
    Enema Kit FCE
    Bath, Sitz, Nonpowered KTC
    Needle, Hypodermic, Single Lumen FMI
    Bedding, Disposable, Medical KME
    Urinal FNP
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Container, Specimen, Non-Sterile NNI
    Non-Surgical Gown OEA
    Tips And Pads, Cane, Crutch And Walker INP
    Container, Specimen, Sterile FMH
    Dispenser, Liquid Medication KYX
    Container, Liquid Medication, Graduated KYW
    Cane IPS
    Crutch IPR
    Culture Media, Non-Propagating Transport JSM
    Basin, Emesis FNY
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Cap, Surgical FYF
    Cover, Shoe, Operating-Room FXP
    Applicator, Absorbent Tipped, Sterile KXG
    Syringe, Irrigating (Non Dental) KYZ
    Stand, Infusion FOX
    Body Fluid Clean Up Kit OKG
    Dish, Tissue Culture KIZ
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Tray, Surgical, Instrument FSM
    Bedpan FOB
    Drape, Surgical, Antimicrobial KKX
    Device, Specimen Collection LIO
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Walker, Mechanical ITJ
    Accessory, Surgical Apparel LYU
    Gown, Examination FME
    Instrument, Manual, Surgical, General Use MDM

    Proprietary Names

    Plastic Clamp Gent-L-Kare Vaginal Irrigation Set Enema Buckets & Kits SITZ BATH MANUAL Sharps Container Towel Wash Cloth Drape Pillow Case Sheet URINAL Calculi Strainer Specimen Containers Specialty Bags Specimen Pan ClickSeal Containers Gown, Isolation Underarm Pads Tips Snap Cap Clik Seal Medicine Cup Tumbler MEDICINE CUP Cane Crutch Multitrans Emesis Bags OR Basin Ring Basin Wash Basins Bowls EMESIS BASIN Eye Shields Cap Shoe Covers Starswab Sampling Swab Syringe - various- Irrigation and Suction BOWL STAND IV Spill Kit Culture Tubes Petri Dish Urinary Leg Bag Urinary Drainage Bag INSTRUMENT TRAYS BEDPAN Swab Histology Containers Walker Barrier Sleeves Apron Gown ; All Purpose Clamp Light Handle Cover

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Sterilize Medical Device for Another Party (Contract Sterilizer)