BEUDAMED
    FDA Registration Active 🇺🇸 United States

    URAMIX, INC.

    Reg #: 2531475 · FEI: 3001642379 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    20
    Establishment Types
    2
    Classifications
    18

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    Registration Details

    Registration Name
    URAMIX, INC.
    Registration Number
    2531475
    FEI Number
    3001642379
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    272 N. LANSDOWNE AVE.
    City
    E Lansdowne
    State
    PA
    ZIP
    19050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223448

    Owner / Operator

    Firm Name
    URAMIX, INC.
    Operator Number
    9032397
    Address
    272 N. LANSDOWNE AVE., --
    City
    Lansdowne
    State
    PA
    Postal Code
    19050
    Country
    US
    Correspondent
    MICHAEL - MOOREVILLE, MD

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    Scissors, General, Surgical LRW
    System, Evacuator, Fluid FHF
    Suprapubic Catheter Accessories QGC
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Retractor, Self-Retaining FFO
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Goniometer, Nonpowered KQW
    Clamp, Non-Electrical FFN
    Penile Implant Surgical Accessories QGA
    Instrument, Biopsy KNW
    Urethrotome EZO
    Tray, Biopsy, Without Biopsy Instruments FCH
    Needle, Gastro-Urology FHR
    Ureteral Stent Accessories QGB
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Snare, Non-Electrical FGX

    Proprietary Names

    Portable Bladder Scanner Wilson Penile Implant Scissors Easy-Jet Irrigator Trans-Urethral Suprapubic Guide (TUSP) URAMIX HugeMed Single-use Ureteroscope Figure "8" Disposable Retractor URAMIX HugeMed Single-use Cystoscope Morey Penometer Wilson Reservoir Pocket Clamp Corpus Ruler-Dilator Mooreville Penile Dilator Corpus Ruler Double-Bladed Advanced Cavernotome (DBAC) URAMIX Curaway Automatic Core Biopsy Instrument Mooreville Urethrotome Instrument Tray Prostate Anesthesia Needle Uramix Hydrophylic Guide Wire THE MOOREVILLE PENI Stent Removing Snare

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility