Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044995029

FEI Number

3044995029

Entity Name

SHUREAR HEALTHCARE (SUZHOU) CO., LTD.

City/State/Country

suzhou Jiangsu, CN

Establishment Address

Fatai Energy Valley G1-509, Kangyuan Road 666, Chengyang Street, Xiangcheng District, suzhou Jiangsu 215131, CN

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shurear Healthcare (Suzhou) Co., Ltd. (Owner Number: 10095505)

Owner / Operator Contact Address

Fatai Energy Valley G1-509, Kangyuan Road 666, Chengyang Street, Xiangcheng District, suzhou, CN-JS 215131, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Prescription Digital Rechargeable BTE-RIC Hearing Aid. igital Rechargeable ITC with Wireless Techonlogy(SH21,SH23,SH25,SH26,SH27,SH28,SH29,SH30) Digital Rechargeable ITC Hearing Aid(SH11,SH12,SH13,SH15,SH16,SH17,SH18,SH19,SH20) Prescription Digital Rechargeable BTE-RIC Hearing Aid(SH01,SH02,SH03,SH05,SH06,SH07,SH08,SH09,SH10) Air Conduction with Wireless Techonlogy, Digital Rechargeable BTE-RIC with Wireless Techonlogy(SH31,SH32,SH35,SH36,SH37,SH39,SH61,SH62,SH63) Hearing Aid, Air Conduction,

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	2026-03-21

Official Correspondent

Kayla Chang

US Agent Details

Peter Yang Business: JIAMEI CONSULTING INC. Email: info@jiameiconsulting.com Phone: (310) 2168437

Related Public Records

Same Entity

Shurear Healthcare (Suzhou) Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044995029. Last updated year: 2026. Please use registration number 3044995029 when referencing this establishment in official correspondence.