XIAMEN NEWSOUND TECHNOLOGY CO., LTD

FDA Device Registration & Listing · Xiamen Fujian, CN · Registration 3007694978

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007694978
FEI Number
3007694978
Entity Name
XIAMEN NEWSOUND TECHNOLOGY CO., LTD
City/State/Country
Xiamen Fujian, CN
Establishment Address
No.13 of Xiangyue Road, Torch Hi-Tech, Industrial Development Zone, Xiang An District, Xiamen Fujian 361001, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Xiamen NewSound Technology Co., Ltd (Owner Number: 10028806)
Owner / Operator Contact Address
No.13 of XiangyueRd.,Torch, Hi-Tech Ind. Dev. Zone, XiangAn District, Xiamen, CN-FJ 361001, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ESD Hearing Aid, Air-Conduction, Prescription Ear, Nose, Throat Class 1 874.3300 2009-03-09
KTH Device, Anti-Stammering Ear, Nose, Throat Class 1 874.5840 2025-01-22
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2022-05-13

Official Correspondent

Shi Hu (David) Yu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: Regrek.Cs@Hotmail.Com Phone: (302) 6089028

Related Public Records

Same Entity

Xiamen NewSound Technology Co., Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K892457 Telstar Electronics, Inc. TELSTAR MODEL 1/3 ITE HEARING AID 1989-06-06
K760996 Unitron Industries, Inc. HEARING AID (MODEL 695D, 905 & 960P) 1976-11-16
K840825 Maico Hearing Instruments, Inc. SERIES MR IN-THE-EAR CUSTOM HEARING AID 1984-03-30
K946253 Maico Hearing Instruments, Inc. MAICO IN-THE-EAR MODEL RD 201 1995-01-30
K863975 Gn Danavox, Inc. CUSTOM IN-THE-EAR 1986-11-07

Similar Registrations

Registration Number Establishment Name Location
3008713760 KENYON AUDIOLOGY Bend, OR, US
3022507139 Zhongrui HearJoy Medical Equipment co., Ltd. Shenzhen Guangdong, CN
3005785669 ALPS INTERNATIONAL NEW DELHI, IN
2523819 MICROSONIC, INC. AMBRIDGE, PA, US
3017618900 HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD huizhou Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007694978. Last updated year: 2026. Please use registration number 3007694978 when referencing this establishment in official correspondence.
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