BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COLOPLAST MANUFACTURING US, LLC

    Reg #: 2125050 · FEI: 2125050 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    33
    Establishment Types
    3
    Classifications
    18

    Registration Details

    Registration Name
    COLOPLAST MANUFACTURING US, LLC
    Registration Number
    2125050
    FEI Number
    2125050
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1601 W River Rd N
    City
    MINNEAPOLIS
    State
    MN
    ZIP
    55411
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221874
    PMA Number
    P020003

    Owner / Operator

    Firm Name
    Coloplast Corp.
    Operator Number
    8010144
    Address
    1601 West River Road North
    City
    Minneapolis
    State
    MN
    Postal Code
    55411
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Testicular FAF
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling PAH
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed OTO
    Stent, Ureteral FAD
    Fixation, Non-Absorbable Or Absorbable, For Pelvic Use PBQ
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Prosthesis, Penile FAE
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN
    Powered Laser Surgical Instrument GEX
    Cannula, Manipulator/Injector, Uterine LKF
    Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse PWK
    Retractor GAD
    Mesh, Surgical, For Stress Urinary Incontinence, Male OTM
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Accessories, Catheter KGZ
    Device, Impotence, Mechanical/Hydraulic FHW

    Proprietary Names

    Torosa Saline-Filled Testicular Prosthesis Altis Single Incision Sling System Meridian Restorelle Y NovoFlow Reinforced Ureteral Stent Saffron Fixation System Furlow Insertion Tool Brooks Dilator Set Rossello Dilator Set Imajin Silicone Hydro-Coated Double Loop Ureteral Stent Genesis Malleable Penile Prosthesis Restorelle Y Contour Restorelle M Restorelle XL Aris Transobturator Kit SabreLine and SabreGuard Laser Fibers Vortek Double Loop Ureteral Stents Meridian Vaginal Positioning System (VPS) Virtue Male Sling System with Alexis Wound Retractor Digitex Suture Delivery System Supris Retropubic Sling System Vortek Hydrocoated Double Loop Ureteral Stent Restorelle L ImaJin Silicone double loop ureteral stent kits ImaJin Pyelostent Silicone double loop ureteral stent kits ImaJin Stenostent Silicone double loop ureteral stent kits Vortek Single Loop Ureteral Stent Restorelle Y Contour Polypropylene Mesh with the Meridian Vaginal Positioning System Scope Insertion Tool Aris Transobturator Sling System Biosoft Duo Double Loop Stent Kit Titan Touch Inflatable Penile Prosthesis Titan Inflatable Penile Prosthesis

    Establishment Types

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