LUXSHARE ELECTRONIC TECHNOLOGY (KUNSHAN) LTD.

FDA Device Registration & Listing · Kunshan Jiangsu, CN · Registration 3040068315

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
3040068315
FEI Number
3040068315
Entity Name
LUXSHARE ELECTRONIC TECHNOLOGY (KUNSHAN) LTD.
City/State/Country
Kunshan Jiangsu, CN
Establishment Address
No.158,Jinchang Road,Jinxi Town,Kunshan City,Jiangsu,P.R.China, Kunshan Jiangsu 215300, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
LUXSHARE ELECTRONIC TECHNOLOGY (KUNSHAN) LTD. (Owner Number: 10094461)
Owner / Operator Contact Address
No.158,Jinchang Road,Jinxi Town,Kunshan City,Jiangsu,P.R.China, Kunshan, CN-JS 215300, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter Ear, Nose, Throat Class 2 874.3325 2026-01-14

Official Correspondent

HAO WEIWEI

US Agent Details

Jerry Doane Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

LUXSHARE ELECTRONIC TECHNOLOGY (KUNSHAN) LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3023339161 TUNED LTD Gan Yoshiya Central, IL
3014337591 HEARX SA Pretoria Gauteng, ZA
3015527983 SOUNDWAVE HEARING, LLC Oak Brook, IL, US
3010841212 EARGO INC San Jose, CA, US
2182204 GN Hearing Care Corporation Shakopee, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040068315. Last updated year: 2026. Please use registration number 3040068315 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.