BEUDAMED
    FDA Registration Active 🇫🇷 France

    COLOPLAST MANUFACTURING FRANCE, SAS

    Reg #: 9610711 · FEI: 3002807917 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    31
    Establishment Types
    3
    Classifications
    12

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    COLOPLAST MANUFACTURING FRANCE, SAS
    Registration Number
    9610711
    FEI Number
    3002807917
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9 Avenue Edmond Rostand, CS 70218
    City
    Sarlat la Caneda Cedex Dordogne
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K211911

    Owner / Operator

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

    US Agent

    Business Name
    COLOPLAST CORP
    Contact Name
    Brian Schmidt
    Address
    1601 West River Road N
    City
    Minneapolis
    State
    MN
    ZIP
    55411
    Country
    US
    Email
    [email protected]
    Phone
    612 8651177

    Products

    Device Name Product Code
    Catheter, Nephrostomy LJE
    Stent, Ureteral FAD
    Dilator, Catheter, Ureteral EZN
    Lavage, Jet FQH
    Catheter, Retention Type, Balloon EZL
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Evacuator, Bladder, Manually Operated FFD
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Catheter, Ureteral, Gastro-Urology EYB
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Catheter, Nephrostomy, General & Plastic Surgery GBO

    Proprietary Names

    Kolibri Percutaneous Nephrostomy Catheters Kolibri Percutaneous Nephrostomy Kits Kolibri Direct Puncture Sets Ureteral Dilators and Percutaneous Nephrostomy Dilators Elefant Suction-Irrigation Device Silicone Prostatectomy Catheter Orchestra Hydrophilic Guidewire EasiVac Biosoft Duo Double Loop Stent Kit Dormia No Tip Dornia N-Stone Dormia DualPerc Floppy Tip Hydro-Coated Ureteric Catheters Flush Ureteric Catheters Ureteric Catheters ImaJin Silicone double loop ureteral stent kits ImaJin Pyelostent Silicone double loop ureteral stent kits ImaJin Stenostent Silicone double loop ureteral stent kits ReTrace Ureteral Access Sheath Vortek Double Loop Ureteral Stents Vortek Hydrocoated Double Loop Ureteral Stent Seldinger Guidewire Soprano Hybrid Guidewire Soprano® Dual Flex-PTFE-Nitinol Guidewire with Straight Hydrophilic Tip with Insertion Tool Soprano®-PTFE-Nitinol Guidewire with Straight Hydrophilic Tip with Insertion Tool Vortek Single Loop Ureteral Stent Imajin Silicone Hydro-Coated Double Loop Ureteral Stent BoNee Needle NovoFlow Reinforced Ureteral Stent Folysil Chiba needle

    Establishment Types

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