BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    VIDEO COLONOCOPE - I10 STANDARD (EC38-I10L)

    Reg #: 3014605202 · FEI: 3014605202 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PENTAX MEDICAL (PENANG) SDN. BHD.
    Registration Number
    3014605202
    FEI Number
    3014605202
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot 554, Lorong Perusahaan 4, Prai Free Trade Zone
    City
    Penang Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K131855

    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

    VIDEO COLONOCOPE - I10 STANDARD (EC38-I10L) VIDEO COLONOSCOPE (EC-3890TLK) VIDEO COLONOSCOPE (EC-3490TLI) VIDEO COLONOSCOPE - I10 SLIM (EC34-I10L) TUBE,IRRIGATION FOR 30/40 SERIES (OF-B113) OE-C14 CHECK VALVE SET-10 PCS. USE WITH (OE-C15) VIDEO COLONOSCOPE (EC-3890LI) A/W VALVE (OF-B188) VIDEO COLONOSCOPE (EC-3890LK) HDVIDEO COLONOSCOPE (EC-3490LI) WATER JET CHECK VALVE ADAPTER REPLACES O (OE-C12) O RING SET FOR OF-B188 (OF-B192) VIDEO COLONOSCOPE (EC-3490LK) VALVE, SUCTION (OF-B120) VIDEO COLONOSCOPE (EC-2990LI) VIDEO COLONOSCOPE (EC-3890LZI) PENTAX Distal Rubber Hood(OE-A59) O-RING MODEL (OF-B182)

    Establishment Types

    Remanufacture Medical Device