BEUDAMED
    FDA Registration Active 🇨🇳 China

    Intra OS DG

    Reg #: 3009608361 · FEI: 3009608361 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD.
    Registration Number
    3009608361
    FEI Number
    3009608361
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 16 Cuiming Road Yat-Sen Scientific In, Tianjin Economic Technological Developme
    City
    Tianjin
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K031118

    Owner / Operator

    Firm Name
    ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD.
    Operator Number
    10040720
    Address
    No 16 Cuiming Road Yat-Sen Scientific In, Tianjin Economic Technological Developme
    City
    Tianjin
    State
    CN-TJ
    Postal Code
    301726
    Country
    CN
    Correspondent
    Jia Song

    US Agent

    Business Name
    P&L Scientific Inc.
    Contact Name
    Jun Peng
    Address
    1430 S. Dixie Highway, Suite 105
    City
    Coral Gables
    State
    FL
    ZIP
    33146
    Country
    US
    Email
    [email protected]
    Phone
    305 3456018

    Products

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

    Proprietary Names

    Intra OS DG Intra Os 70

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device