BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    MYCO Medical

    Reg #: 9614747 · FEI: 3001738911 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KOBAYASHI SHOJI K.K.
    Registration Number
    9614747
    FEI Number
    3001738911
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NMF Yokohama Nishiguchi Bldg., No. 11-11, 1-Chome
    City
    Kitasaiwai, Nishi-Ku, Yokohama Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K160269

    Owner / Operator

    Firm Name
    KOBAYASHI SHOJI K.K.
    Operator Number
    9038953
    Address
    NMF Yokohama Nishiguchi Bldg., No. 11-11, 1-Chome
    City
    Kitasaiwai, Nishi-Ku, Yokohama
    State
    Kanagawa
    Postal Code
    220-0004
    Country
    JP

    US Agent

    Business Name
    MYCO MEDICAL SUPPLIES, INC.
    Contact Name
    SANJIV KUMAR
    Address
    2015 Production Dr
    City
    Apex
    State
    NC
    ZIP
    27539
    Country
    US
    Email
    [email protected]
    Phone
    919 4602535 ext. 105

    Products

    Device Name Product Code
    Mask, Surgical FXX

    Proprietary Names

    MYCO Medical

    Establishment Types

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