Xiamen Newsound Technology Co., Ltd.
Registered establishment in Xiamen, Fujian, China. 7 device types.
Xiamen Newsound Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Curette, Ear, Face Plate Hearing Aid and 5 other device types. Its earliest product listing with the FDA dates from 2009.
Registration
| Registered name | XIAMEN NEWSOUND TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007694978 |
| FEI number | 3007694978 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | No.13 of Xiangyue Road, Torch Hi-Tech |
| Postal code | 361001 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Curette, Ear | Class 1 | LightBeam Ear Curettes and Tweezers with Magnification | 2022 | 9 |
| Device, Anti-Stammering | Class 1 | FluencyPods | 2025 | 1 |
| Face Plate Hearing Aid | Class 1 | Class D; Cleartone; Puretone; Realtone; Supertone; Wing | 2019 | 11 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | Class 2 | Sigma Plus; Sona; TE103; Tweak Enhance, elclear 9106;, BW21, BW51, BW52, BW53;clearcast, VAN 610 Pro,VAN 203 Pro, Groove; HioNec FIT; LIVE series;, Poco X903, Poco MA6461,Primo DR6401 and 4 more | 2022 | 52 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | Class 2 | Primo SA, Primo RA, Primo MA; Sigma+; Sona; Ulite2000, 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); | 2019 | 29 |
| Hearing Aid, Air-Conduction, Over The Counter | Class 1 | 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; Primo C601, B10; BEE III 101; DX4, DX8; EA4; EasyCharge, EasyCharge Pro; Encore; EX2; GMS-HA23; Helix; MAT4;Primo C601 | 2022 | 57 |
| Hearing Aid, Air-Conduction, Prescription | Class 1 | DX400, DX800; EA40;EU1021, EU1061; GMS-HA17; MA41T; Pro 20;, RIE400; Rocker 200, Rocker 400, Rocker 600, Rocker 800; RV4B; SAP40T;, CMS11H, CMS12H;, Van Pro 200, Van Pro 201, Van Pro 400, Van Pro 800;, Aria 200, Aria 206, Aria 800, Aria 810; Asana, Asana 220, Asana Pro 200, Asana Pro 400, Asana Pro 600;, Vivo, Vivo 201, Vivo 202, Vivo 206, Vivo 106 FLEX, Vivo Pro 102; Ziv 209 and 1 more | 2009 | 45 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Main products | Hearing aids, Hearing solutions, Audio devices |
| Certifications | ISO13485, CE, FDA, Korea KHMP |
| Export markets | 100+ countries globally |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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