BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    OZAKI AVNeo(R) Sizer System

    Reg #: 3010805418 · FEI: 3010805418 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sanamedi, Inc.
    Registration Number
    3010805418
    FEI Number
    3010805418
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #601 Nihonbashi Life Science Building, 2-3-11 Nihonbashi-Honcho
    City
    Chuo-ku Tokyo
    Country
    JP

    Owner / Operator

    Firm Name
    Sanamedi, Inc.
    Operator Number
    10046345
    Address
    601 Nihonbashi LIfe Science Building, 2-3-11 Nihonbashi-Honcho, Chuo-ku
    City
    Tokyo
    State
    JP-13
    Postal Code
    103-0023
    Country
    JP
    Correspondent
    Takahiro Uchida

    US Agent

    Business Name
    510K Technology Group LLC
    Contact Name
    Kachi Enyinna
    Address
    1337 Mass Ave, #286
    City
    Arlington
    State
    MA
    ZIP
    02476
    Country
    US
    Email
    [email protected]
    Phone
    617 8704055

    Products

    Device Name Product Code
    Sizer, Heart-Valve, Prosthesis DTI

    Proprietary Names

    OZAKI AVNeo(R) Sizer System OZAKI VRec Sizer System (19mm, 21mm, 23mm, 25mm, 27mm, 29mm, 31mm, 33mm, 35mm) OZAKI AVNeo(R) Sizer (31, 33, 35) OZAKI VRec Sizer (13mm, 15mm, 17mm) Heart Valve Sizer and Template OZAKI AVNeo(R) Sizer (13, 15, 17)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility