Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011350813

FEI Number

3011350813

Entity Name

HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 401, No.2 Building, No.1390 Cangxing Street, Yuhang, Hangzhou Zhejiang 311100, CN

Establishment Type(s)

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

Owner / Operator

Hangzhou Acosound Technology Co., Ltd. (Owner Number: 10053274)

Owner / Operator Contact Address

Room 401, No.2 Building, No.1390 Cangxing Street, Yuhang, Hangzhou, CN-ZJ 311100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

430-RIC Celesto-RIC-M Leya-IF-P Celesto-RIC-S Leya-RIC-M AI-2 Leya-IF-P-N Leya-RIC-S-N Celesto-IF Leya-IF-N Leya-BTE-M-N Leya-RIC-M-N Leya-BTE-P-N Leya-BTE-H-N Leya-IF AI-1 610IF AI-3 LQC-IF-P Celesto-BTE-M Leya-BTE-M Ruby(HA Faceplate) TINNITUS MASKER Leya-RIC-S Celesto-IF-P Celesto-W-IF-P Leya-W-RIC-S Leya-W-BTE-M Leya-W-IF Leya-ITC TW-IF-P Leya-W-RIC-M Celesto-W--RIC-M TW-RIC-C Celesto-W--BTE-M TW-RIC-M TW-IF-C Sonar Pro Leya-W-IF-P Celesto-W-IF Celesto-W--RIC-S M-10 ACOMATE M-10 420 BTE C-118 ACOMATE RECHARGER PLUS Celesto-BTE-H ACOMATE RECHARGER 410-BTE-Plus ACOMATE RECHARGER(C-118) Leya-BTE-H ACOMATE ANAYA PLUS Celesto-BTE-P Leya-BTE-P Celesto-W-BTE-H Leya-W-BTE-P Celesto-W-BTE-P Leya-W-BTE-H

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2022-11-08
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2022-11-08
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2016-11-16
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2022-11-08

Official Correspondent

Lingling Wang

US Agent Details

Maple Chen Business: GVM MEDICAL LLC Email: info@gvmmedical.com Phone: (610) 4517988

Related Public Records

Same Entity

Hangzhou Acosound 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

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3016157573	ZHUHAI ZOROSY TECHNOLOGY CO., LTD.	Zhuhai Guangdong, CN
3022507139	Zhongrui HearJoy Medical Equipment co., Ltd.	Shenzhen Guangdong, CN
3027300374	SHENZHEN AKAUDIO CO., LIMITED	Shenzhen Guangdong, CN
3033659461	SHENZHEN SOUNDS GOOD TECHNOLOGIES CO., LTD	Shenzhen Guangdong, CN
3008460009	Shenzhen Zhongde Audio-Technical Co., Ltd.	Shenzhen City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011350813. Last updated year: 2026. Please use registration number 3011350813 when referencing this establishment in official correspondence.