BEUDAMED
    FDA Registration Active 🇨🇳 China

    VERSA-DIAL 50X21X57 HUM HEAD

    Reg #: 3004748528 · FEI: 3004748528 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SHANGHAI JPY ION-TECH CO., LTD.
    Registration Number
    3004748528
    FEI Number
    3004748528
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 1168, HUIJIN ROAD, QINGPU INDUSTRIAL ZONE
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K060716

    Owner / Operator

    Firm Name
    SHANGHAI JPY ION-TECH CO., LTD.
    Operator Number
    9066119
    Address
    NO. 1168, HUIJIN ROAD, QINGPU INDUSTRIAL ZONE
    City
    SHANGHAI
    State
    CN-NOTA
    Postal Code
    201707
    Country
    CN

    US Agent

    Business Name
    MANTON BUSINESS & TECHNOLOGY SERVICES, LLC
    Contact Name
    Charles Shen
    Address
    37 Winding Rdg
    City
    Oakland
    State
    NJ
    ZIP
    07436
    Country
    US
    Email
    [email protected]
    Phone
    608 2179358

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD

    Proprietary Names

    VERSA-DIAL 50X21X57 HUM HEAD VERSA-DIAL 38X19X39 HUM HEAD VERSA-DIAL 46X24X47 HUM HEAD VERSA-DIAL 50X27X50 HUM HEAD VERSA-DIAL 38X21X38 HUM HEAD VERSA-DIAL 58X27X61 HUM HEAD VERSA-DIAL 50X24X52 HUM HEAD VERSA-DIAL 54X21X64 HUM HEAD VERSA-DIAL 54X24X58 HUM HEAD VERSA-DIAL 46X21X50 HUM HEAD VERSA-DIAL 46X27X46 HUM HEAD VERSA-DIAL 54X27X55 HUM HEAD VERSA-DIAL 46X18X53 HUM HEAD VERSA-DIAL 58X24X64 HUM HEAD VERSA-DIAL 42X18X46 HUM HEAD VERSA-DIAL 42X24X42 HUM HEAD VERSA-DIAL 42X21X43 HUM HEAD

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)