Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008460009

FEI Number

3008460009

Entity Name

Shenzhen Zhongde Audio-Technical Co., Ltd.

City/State/Country

Shenzhen City Guangdong, CN

Establishment Address

8th Floor,buliding A,Xinlong Science and Technology Park,ShaJing ZhuangCun Road No.50, Shajing Town,BaoAn District, Shenzhen City Guangdong 518104, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shenzhen Zhongde Audio-Technical Co.,Ltd. (Owner Number: 10072262)

Owner / Operator Contact Address

208, No. 3 Xinfa South Road, Xinfa Industrial Zone, Xiangshan Community, Xinqiao Street, Bao'an District, Shenzhen, CN-GD 518104, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

hearing aid Thermometer digital hearing aid

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	2022-12-21
PXH	Thermometer Kit	General Hospital	Class 2	880.2910	2020-04-28
LRB	Face Plate Hearing Aid	Ear, Nose, Throat	Class 1	874.3300	2020-04-28

Official Correspondent

Zhengdong Huang

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Shenzhen Zhongde Audio-Technical 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 3008460009. Last updated year: 2026. Please use registration number 3008460009 when referencing this establishment in official correspondence.