BEUDAMED
    FDA Registration Active 🇨🇳 China

    ActiGraph LEAP

    Reg #: 3012324979 · FEI: 3012324979 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN FENDA TECHNOLOGY CO., LTD.
    Registration Number
    3012324979
    FEI Number
    3012324979
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Fenda Hi-Tech Park Zhoushi Road Shiyan, BaoAn
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K231532

    Owner / Operator

    Firm Name
    SHENZHEN FENDA TECHNOLOGY CO., LTD.
    Operator Number
    10051582
    Address
    Fenda Hi-Tech Park, Zhoushi Road Shiyan, Bao'an
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518108
    Country
    CN
    Correspondent
    ADEE LIU

    US Agent

    Business Name
    Mars register agent LLC
    Contact Name
    Jessie Peng
    Address
    8932 Mission Dr Unit 207
    City
    Rosemead
    State
    CA
    ZIP
    91770
    Country
    US
    Email
    [email protected]
    Phone
    818 5797288

    Products

    Device Name Product Code
    Device, Sleep Assessment LEL

    Proprietary Names

    ActiGraph LEAP

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)