BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    FIBEROPTIC COLONOSCOPE (FC-38LV-OUS)

    Reg #: 3012414760 · FEI: 3012414760 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Pentax Medical
    Registration Number
    3012414760
    FEI Number
    3012414760
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6715 Millcreek Drive, Unit 1
    City
    Mississauga Ontario
    Country
    CA

    Owner / Operator

    Firm Name
    HOYA Corporation PENTAX Division
    Operator Number
    8030235
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    Postal Code
    07645
    Country
    US
    Correspondent
    Gurvinder Nanda

    US Agent

    Business Name
    HOYA CORPORATION PENTAX DIVISION
    Contact Name
    Gurvinder Nanda
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    ZIP
    07645
    Country
    US
    Email
    [email protected]
    Phone
    201 5712318

    Products

    Device Name Product Code
    Colonoscope And Accessories, Flexible/Rigid FDF

    Proprietary Names

    FIBEROPTIC COLONOSCOPE (FC-38LV-OUS) DISTAL RUBBER HOOD (OE-A59) VIDEO COLONOSCOPE (EC38-i10NL-OUS) VIDEO COLONOSCOPE - CLASSIC LINE (EC-380LKP) VIDEO COLONOSCOPE (EC38-i10NF-OUS) VIDEO COLONOSCOPE (EC34-I10TL) VIDEO COLONOSCOPE - PTAH (EC38-V10CM-OUS) VIDEO COLONOSCOPE - PTAH (EC38-V10CL-OUS) VIDEO COLONOSCOPE (EC38-I10CL) IMAGINA VENTING CAP (OE-C28) VIDEO COLONOSCOPE (EC34-i10L-OUS) VIDEO COLONOSCOPE (EC38-i10L-OUS) VIDEO COLONOSCOPE (EC34-I10NL-OUS) VIDEO COLONOSCOPE (EC34-I10CL-OUS) CLEANING ADAPTER (OE-C27) PENTAX Medical Cylinder Cleaning Adapter (OE-B16) PENTAX MEDICAL VIDEO COLONOSCOPE (EC38-i20cL) PENTAX Medical Suction Control Valve (OE-B13) PENTAX Medical Air/Water Feeding Valve (OE-B12) PENTAX Medical Water Jet Channel Cleaning Adapter (OE-C31) PENTAX Medical Air/Water Channel Cleaning Adapter (OE-B15) PENTAX Medical Gas/Water Feeding Valve (OE-B14)

    Establishment Types

    Remanufacture Medical Device