Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013596029

FEI Number

3013596029

Entity Name

ZHONGSHAN GREAT-EARS ELECTRONIC TECHNOLOGY CO.,LTD

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

3rd/F No. 35 West Road, Dongsheng Tongmao Industrial Park, Xiao Lan Town, Zhongshan Guangdong 528401, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Zhongshan Great-ears Electronic Technology Co.,Ltd (Owner Number: 10053886)

Owner / Operator Contact Address

3rd/F No. 35 West Road, Dongsheng Tongmao Industrial Park, Xiao Lan Town, Zhongshan, CN-GD 528401, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

G-51, G-52, G-53, G-55, G-56, G-57, G-59, G-60, G-70, G-72, G-73, G-75, G-75D, G-76, G-77, G-79, G-90, G-92, G-93, G-95, G-96, G-97, G-99 G-10, G-11, G-11L, G-12, G-13, G-15, G-16, G-16D, G-17, G-17D, G-18, G-18C, G-18D, G-19, G-19D, G-20, G-20B, G-21, G-22, G-31, G-31L, G-32, G-32D, G-33, G-33D, G-35, G-36, G-36L, G-37, G-37D, G-39, G-50, G-22D, G-23, G-25, G-25BT, G-25C, G-25D, G-25L, G-26, G-26C, G-27, G-27P, G-28, G-28C, G-28D, G-28RIC, G-29, G-29D, G-30 G-35, G-36, G-36L, G-37, G-37D, G-39, G-50 G-51, G-52, G-53, G-55, G-56, G-57, G-59, G-60, G-77, G-79, G-90, G-92, G-93, G-95, G-96, G-97, G-99 G-10, G-10L, G-11, G-11D, G-11L, G-12, G-13, G-13D, G-15, G-15D, G-15L, G-16, G-16C, G-16D, G-17, G-17D, G-18, G-18C, G-18D, G-19, G-19D, G-20, G-20B, G-21, G-22, G-22D, G-23, G-23D, G-25, G-25BT, G-25C, G-25D, G-25L, G-26, G-26C, G-26D, G-27, G-27D, G-27P, G-28, G-28C, G-28D, G-28L, G-28RIC, G-29, G-29D, G-30, G-30D, G-31, G-31L, G-32, G-32D, G-33, G-33D, H10 M16 H19 RLT-SL M11 H11 H12 Y11 H16 M17 H15 RLT-M210 Y16 RLT-JC101 M19 Y10 M15 Y17 Y12 H13 Y15 M12 RLT-M3600 Y13 M13 H17 RLT-M360 Y19 M10 RLT-JC70

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	2022-12-29
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2017-01-19
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2026-06-02

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Zhongshan Great-ears Electronic 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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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 3013596029. Last updated year: 2026. Please use registration number 3013596029 when referencing this establishment in official correspondence.