BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    OSferion

    Reg #: 3007738819 · FEI: 3007738819 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OLYMPUS TERUMO BIOMATERIALS CORP. Mishima Factory
    Registration Number
    3007738819
    FEI Number
    3007738819
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    454-1 Higashino, Nagaizumi-cho
    City
    Sunto-gun Shizuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K080065

    Owner / Operator

    Firm Name
    OLYMPUS TERUMO BIOMATERIALS CORP.
    Operator Number
    9087979
    Address
    1-50-1 Sasazuka
    City
    Shibuya-ku
    State
    Tokyo
    Postal Code
    151-0073
    Country
    JP

    US Agent

    Business Name
    Registrar Corp.
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

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

    Proprietary Names

    OSferion

    Establishment Types

    Manufacture Medical Device