BEUDAMED
    FDA Registration Active 🇨🇳 China

    XIAMEN NEWSOUND TECHNOLOGY CO., LTD

    Reg #: 3007694978 · FEI: 3007694978 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    26
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    XIAMEN NEWSOUND TECHNOLOGY CO., LTD
    Registration Number
    3007694978
    FEI Number
    3007694978
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.13 of Xiangyue Road, Torch Hi-Tech, Industrial Development Zone, Xiang An District
    City
    Xiamen Fujian
    Country
    CN

    Owner / Operator

    Firm Name
    Xiamen NewSound Technology Co., Ltd
    Operator Number
    10028806
    Address
    No.13 of XiangyueRd.,Torch, Hi-Tech Ind. Dev. Zone, XiangAn District
    City
    Xiamen
    State
    Fujian
    Postal Code
    361001
    Country
    CN
    Correspondent
    Shi Hu (David) Yu

    US Agent

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

    Products

    Device Name Product Code
    Hearing Aid, Air-Conduction, Prescription ESD
    Device, Anti-Stammering KTH
    Curette, Ear JYG
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM
    Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter QUG
    Hearing Aid, Air-Conduction, Over The Counter QUF
    Face Plate Hearing Aid LRB

    Proprietary Names

    DX400, DX800; EA40;EU1021, EU1061; GMS-HA17; MA41T; Pro 20; Vivo, Vivo 201, Vivo 202, Vivo 206, Vivo 106 FLEX, Vivo Pro 102; Ziv 209 Van Pro 200, Van Pro 201, Van Pro 400, Van Pro 800; Aria 200, Aria 800, Aria 810; Asana, Asana 220, Asana Pro 200, Asana Pro 400, Asana Pro 600; RIE400; Rocker 200, Rocker 400, Rocker 600, Rocker 800; RV4B; SAP40T; VAN 210, VAN 401, VAN 610, VAN 810; Van Plus 200, Van Plus 400, Van Plus 800; CMS11H, CMS12H; FluencyPods LightBeam Ear Curettes and Tweezers with Magnification POCO SA; POCO X, POCO X403, POCO X405, POCO X406, POCO X601, POCO X808, POCO X818,; EON; Forte MA; HA-802, HA-900; OIDO Hearing(MA); Primo SA, Primo RA, Primo MA; Sigma+; Sona; Ulite2000 Groove; HioNec FIT; LIVE series; Primo DR6491 VAN 610 Pro,VAN 203 Pro elclear 9106; BW21, BW51, BW52, BW53; Poco MU803;Poco MA6461; Primo MA401, Primo SA401, Primo DA801;Primo DR6401 Flow Poco X903, Poco MA6461,Primo DR6401 PB-A01 Sigma Plus; Sona; TE103; Tweak Enhance Poco M201, Poco M401; Poco Q101; Poco Z101, Poco Z401; Primo M401, Primo R401, Primo S401; PURE series; Rocker 202, Rocker 402; Smart 401; TactEar 801; Whisper B10; BEE III 101; DX4, DX8; EA4; EasyCharge, EasyCharge Pro; Encore; EX2; GMS-HA23; Helix; MAT4; Class D; Cleartone; Puretone; Realtone; Supertone; Wing

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device