BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Pentax Video Colonoscope (EC38-i20cL)

    Reg #: 3003782610 · FEI: 3003782610 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    HOYA Corporation PENTAX Lifecare Division
    Registration Number
    3003782610
    FEI Number
    3003782610
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30-2 Okada, Aza-Shimomiyano, Tsukidate
    City
    KURIHARA-SHI Miyagi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K231249

    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
    Gastroscope And Accessories, Flexible/Rigid FDS
    Endoscope, Accessories, Image Post-Processing For Color Enhancement PEA
    Colonoscope And Accessories, Flexible/Rigid FDF

    Proprietary Names

    Pentax Video Colonoscope (EC38-i20cL) PENTAX Medical Video Upper GI Scope EG29- i20c PENTAX Medical Water Jet Channel Cleaning Adapter OE-C31 PENTAX Medical Air/Water Channel Cleaning Adapter OE-B15 PENTAX Medical Keyboard EN OS-A115 PENTAX Medical Suction control valve OE-B13 PENTAX Medical Air/Water feeding Valve OE-B12 PENTAX White Balance Adjuster (OS-A43) PENTAX Medical Cylinder Cleaning Adapter (OE-B16) PENTAX Medical Video Processor EPK-i8020c

    Establishment Types

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