BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PHOT-X-IIS Model 505

    Reg #: 3010972172 · FEI: 3010972172 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Takara Medical Co., Ltd.
    Registration Number
    3010972172
    FEI Number
    3010972172
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5-15, Nukata-cho
    City
    Amagasaki Hyogo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K141293

    Owner / Operator

    Firm Name
    TAKARA BELMONT CORPORATION
    Operator Number
    8031613
    Address
    2-1-1, HIGASHISHINSAIBASHI, CHUO-KU
    City
    OSAKA
    State
    JP-27
    Postal Code
    542-0083
    Country
    JP
    Correspondent
    HITOMI - TOKUDA

    US Agent

    Business Name
    TAKARA BELMONT USA, INC.
    Contact Name
    Gary Stern
    Address
    101 Belmont Dr
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US
    Email
    [email protected]
    Phone
    732 4695000 ext. 1155

    Products

    Device Name Product Code
    Unit, X-Ray, Extraoral With Timer EHD

    Proprietary Names

    PHOT-X-IIS Model 505

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device