Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025427079

FEI Number

3025427079

Entity Name

SHENZHEN TONYCORE TECHNOLOGY CO.,LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 808, Xinlong Building, Minzhi Street, Longhua District, Shenzhen Guangdong 518131, CN

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shenzhen TonyCore Technology Co.,Ltd. (Owner Number: 10086486)

Owner / Operator Contact Address

Room 808, Xinlong Building, Minzhi Street, Longhua District, Shenzhen, CN-GD 518131, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hearing Aid, Amplifiers With Models G001 G002 G003 G004 G005 G006 G007 G008 G009 G010 G011 G012 G013 G014 G015 G016 G017 G018 G019 G020 G021 G022 G023 G024 G025 G026 G027 G028 G029 G030 T016 T017 T018 T019 T020 T021 T022 T023 T024 T025 T026 T027 T028 T029 T030 Wireless Bluetooth Hearing Aid/Amplifier T001 T002 T003 T004 T005 T006 T007 T008 T009 T010 T011 T012 T013 T014 T015

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2023-01-15
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2022-11-13

Official Correspondent

JiaChuan Lin

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shenzhen TonyCore Technology 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 3025427079. Last updated year: 2026. Please use registration number 3025427079 when referencing this establishment in official correspondence.