BEUDAMED
    FDA Registration Active 🇨🇳 China

    Hearing Aid, Amplifiers With Models D001 D002 D003 D004 D005 D006 D007 D008 D009 D010 D011 D012 D013 D014 D015 D016

    Reg #: 3025427079 · FEI: 3025427079 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN TONYCORE TECHNOLOGY CO.,LTD.
    Registration Number
    3025427079
    FEI Number
    3025427079
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 808, Xinlong Building, Minzhi Street, Longhua District
    City
    Shenzhen Guangdong
    Country
    CN

    Owner / Operator

    Firm Name
    Shenzhen TonyCore Technology Co.,Ltd.
    Operator Number
    10086486
    Address
    Room 808, Xinlong Building, Minzhi Street, Longhua District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518131
    Country
    CN
    Correspondent
    JiaChuan Lin

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Hearing Aid, Air-Conduction, Over The Counter QUF

    Proprietary Names

    Hearing Aid, Amplifiers With Models D001 D002 D003 D004 D005 D006 D007 D008 D009 D010 D011 D012 D013 D014 D015 D016 D017 D018 D019 D020 D021 D022 D023 D024 D025 D026 D027 D028 D029 D030

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device