BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ReBOSSIS QDS

    Reg #: 3013497559 · FEI: 3013497559 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Kaigen Pharma Co., Ltd. Tenjin Factory
    Registration Number
    3013497559
    FEI Number
    3013497559
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2-5-3 Tenjin
    City
    Otaru-shi Hokkaido
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K170620

    Owner / Operator

    Firm Name
    Kaigen Pharma Co.,Ltd.
    Operator Number
    10052192
    Address
    2-5-3 Tenjin
    City
    Otaru-shi
    State
    Hokkaido
    Postal Code
    047-0011
    Country
    JP

    US Agent

    Business Name
    PaxMed International LLC
    Contact Name
    Floyd Larson
    Address
    1925 Palomar Oaks Way Ste 210
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US
    Email
    [email protected]
    Phone
    858 7921235

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    ReBOSSIS QDS ReBOSSIS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)