HomeChinaXiamen NewSound Technology Co.,Ltd

Xiamen NewSound Technology Co.,Ltd

China · www.newsound.cn
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000041673Unified social credit code 91350200751648094L

This company holds 7 NMPA certificates in China and has registrations in European Union, United States, Canada, Israel, Russia — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
7China registrations
Class II 7
as of 2026-09-04
EUEuropean UnionEUDAMED
100UDI-DI device records
Class IIa 100
USUnited StatesFDA openFDA
7listed device types
Class I 5Class II 2Class III 0
plus 7 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union100 raw hits, 0 excluded, 100 confirmed
United States7 registration records, 0 510(k), 0 PMA
China7 certificates (Class III 0 / II 7 / I 0), as of 2026-09-04
Manufacturer names merged into this page: XIAMEN NEWSOUND TECHNOLOGY CO., LTD · XIAMEN NEWSOUND TECHNNOLOGY, CO. LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000041673
EU authorised representative
Prolinx GmbH
Unified social credit code
91350200751648094L
Exhibition record
Rehab & Elderly Care Expo (Spring 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
90
Annual revenue
RMB 100–500M
Website
www.newsound.cn
Product categories
家用器械

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2004-05-12
Registered capital
CNY 12,000,000
Paid-in capital
CNY 12,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2022-05-26
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseGazelle enterprise

Business registration data from Tianyancha, as of 2026-09-03. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA listed device types

Hearing Aid, Air-Conduction, Over The Counter 1Hearing Aid, Air-Conduction, Prescription 1Face Plate Hearing Aid 1Device, Anti-Stammering 1Curette, Ear 1Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 1

Registration details (sample)

MarketIdentifierNameClass / date
CN闽械注准20252190272盒式助听器Class II
CN闽械注准20252190175耳背式助听器Class II
CN闽械注准20252190174耳背式助听器Class II
CN闽械注准20232190101盒式助听器Class II
EU06945936704544Poco R401Class IIa
EU06945936705534CleartoneClass IIa
EU06945936705503HuishengClass IIa
EU06945936705497SupertoneClass IIa

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