BEUDAMED
    FDA Registration Active 🇨🇳 China

    MR Conditional Sticky Pad Electrode

    Reg #: 3006697681 · FEI: 3006697681 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PINE MOON ELECTRONICS CO., LTD.
    Registration Number
    3006697681
    FEI Number
    3006697681
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SIXTH AND SEVENTH FLOOR, BUILDING B, EIGHTH FLOOR BUILDING A, 22ND HUANPING ROAD, GAOQIAO COMMUNITY, PINGDI STREET, LONGGANG DISTRICT
    City
    SHENZHEN CITY Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K203079

    Owner / Operator

    Firm Name
    RHYTHMLINK INTERNATIONAL, LLC
    Operator Number
    9052354
    Address
    1140 FIRST ST. SOUTH, --
    City
    Columbia
    State
    SC
    Postal Code
    29209
    Country
    US
    Correspondent
    Sandra O'Reilly

    US Agent

    Business Name
    Rhythmlink International LLC
    Contact Name
    Sandra O'Reilly
    Address
    1140 First Street South
    City
    Columbia
    State
    SC
    ZIP
    29209
    Country
    US
    Email
    [email protected]
    Phone
    678 3341720

    Products

    Device Name Product Code
    Electrode, Cutaneous GXY

    Proprietary Names

    MR Conditional Sticky Pad Electrode

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)