BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    KARL STORZ ENDOSCOPY CANADA LTD.

    Reg #: 3012322232 · FEI: 3012322232 · Expires 2026
    View on FDA
    Products
    62
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    62

    Registration Details

    Registration Name
    KARL STORZ ENDOSCOPY CANADA LTD.
    Registration Number
    3012322232
    FEI Number
    3012322232
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7171 Millcreek Drive
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K061541
    PMA Number
    P050028

    Owner / Operator

    Firm Name
    KARL STORZ Endoscopy Canada Ltd.
    Operator Number
    10084187
    Address
    7171 Millcreek Drive
    City
    Mississauga
    State
    Ontario
    Postal Code
    L5N 3R3
    Country
    CA
    Correspondent
    Diana Faddoul

    US Agent

    Business Name
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Contact Name
    Anja Fair
    Address
    2151 E Grand Ave
    City
    El Segundo
    State
    CA
    ZIP
    90245
    Country
    US
    Email
    [email protected]
    Phone
    346 8168200

    Products

    Device Name Product Code
    Hepatitis Viral B Dna Detection MKT
    Camera, Surgical And Accessories KQM
    Electrode, Electrosurgical, Active, Urological FAS
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    System, Imaging, Fluorescence MRK
    Urethroscope FGC
    Hysteroscope (And Accessories) HIH
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Mediastinoscope, Surgical EWY
    Esophagoscope (Flexible Or Rigid) EOX
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Otoscope ERA
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Led Light Source NTN
    Powered Laser Surgical Instrument GEX
    Forceps, General & Plastic Surgery GEN
    Holder, Needle, Gastroenterologic FHQ
    Laryngoscope, Rigid CCW
    Bronchoscope (Flexible Or Rigid) EOQ
    Laparoscope, General & Plastic Surgery GCJ
    Instrument, Surgical, Non-Powered HAO
    Light Source, Fiberoptic, Routine FCW
    Light Source, Endoscope, Xenon Arc GCT
    Amnioscope, Transabdominal (Fetoscope) (And Accessories) HFA
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Endoscopic Irrigation/Suction System OCX
    System, Irrigation, Urological LJH
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Insufflator, Hysteroscopic HIG
    Endoscope, Neurological GWG
    Arthroscope HRX
    Insufflator, Laparoscopic HIF
    Insufflator, Endoscopic Vessel Harvesting OSV
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Curette, Uterine HCY
    Camera, Television, Endoscopic, Without Audio FWF
    Laparoscope, Gynecologic (And Accessories) HET
    Attachment, Eyepiece, For Insertion Of Prescription Lens FDZ
    Microscope, Surgical EPT
    Accessories, Arthroscopic NBH
    Accessories, Catheter, G-U KNY
    Saw, Surgical, Ent (Electric Or Pneumatic) EWQ
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Electrode, Electrosurgical JOS
    Cystourethroscope FBO
    System, Image Processing, Radiological LLZ
    Neurological Stereotaxic Instrument HAW
    Instrument, Manual, Surgical, General Use MDM
    Confocal Optical Imaging OWN
    Resectoscope, Working Element FDC
    Resectoscope FJL
    Bougie, Esophageal, Ent KCD
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Forceps, Biopsy, Non-Electric FCL
    Bulb, Inflation, For Endoscope FCY
    Urethrotome EZO
    Bougie, Urological FAX
    Dilator, Catheter, Ureteral EZN
    Dilator, Urethral, Mechanical FAH
    Dilator, Urethral KOE
    Accessories, Cleaning Brushes, For Endoscope MNL

    Proprietary Names

    KARL STORZ SE & CO. KG

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device