BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Reality Ultra Lubricated

    Reg #: 8030344 · FEI: 3002808077 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SAGAMI RUBBER INDUSTRIES CO., LTD.
    Registration Number
    8030344
    FEI Number
    3002808077
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2-1, MOTO-CHO
    City
    ATSUGI-SHI Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K113686

    Owner / Operator

    Firm Name
    SAGAMI RUBBER INDUSTRIES CO., LTD.
    Operator Number
    9001731
    Address
    2-1 MOTO-CHO, ATSUGI-SHI
    City
    KANAGAWA-KEN
    State
    JP-NOTA
    Postal Code
    243-0002
    Country
    JP

    US Agent

    Business Name
    Mayer Laboratories
    Contact Name
    David Mayer
    Address
    1400 Shattuck Ave.,, Suite 9
    City
    Berkeley
    State
    CA
    ZIP
    94709
    Country
    US
    Email
    [email protected]
    Phone
    510 2295300 ext. 5305

    Products

    Device Name Product Code
    Condom HIS

    Proprietary Names

    Reality Ultra Lubricated Kimono MicroThin with Aqua Lube

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device