Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022507139

FEI Number

3022507139

Entity Name

Zhongrui HearJoy Medical Equipment co., Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

401, Building 1, No. 106, Zhuangcun Road, Xin er Community, Xinqiao Street, Bao an District, Shenzhen Guangdong 518000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhongrui HearJoy Medical Equipment co., Ltd. (Owner Number: 10084620)

Owner / Operator Contact Address

401, Building 1, No. 106, Zhuangcun Road, Xin'er Community, Xinqiao Street, Bao'an District, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ZR-H712, ZR-H713, ZR-H715, ZR-H716, ZR-H717, ZR-H718, ZR-711A, ZR-H715A, ZR-H716A, ZR-H718A, ZR-G300, ZR-M93, ZR-M95, Z100, Z101, Z102, Z103, Z105, Z10, Z107, Z108, Z109) ZR-M96, ZR-M97, ZR-M98, ZR-M99, ZR-M92BT, ZR-M93BT, ZR-M94BT, ZR-M95BT, ZR-M96BT, ZR-M97BT, ZR-M98BT, ZR-M99BT, ZR-E16, Hearing aids (ZR-HA01, ZR-HA02, ZR-HA03, ZR-H701, ZR-H702, ZR-H703, ZR-H704, ZR-H705, ZR-H706, ZR-H710, ZR-E109, ZR-E32, ZR-E64, ZR-E100, ZR-E101, ZR-E102, ZR-E103, ZR-E105, ZR-E106, ZR-E107, ZR-E108, E107, E108, E109, ZR-100, ZR-101, ZR-102, ZR-103, ZR-105, ZR-106, ZR-107, ZR-108, ZR-109, E100, E101, E102, E103, E105, E106, ZR-G400, ZR- G500, ZR-G600, ZR-G700, ZR-G800, ZR-M902, ZR-M903, ZR-M904, ZR-M905, ZR-M906, ZR-M907, ZR-M908, ZR-M92, ZR-H711, Hearing aids (ZR-HA01, ZR-HA02, ZR-HA03, ZR-H701, ZR-H702, ZR-H703, ZR-H704, ZR-H705, ZR-H706, ZR-H710, ZR-H711, ZR-H712, ZR-H713, ZR-H715, ZR-H716, ZR-H717, ZR-H718, ZR-711A, ZR-H715A, ZR-H716A, ZR-H718A, ZR-G300, ZR-M98BT, ZR-M99BT, ZR-E16, ZR-E32, ZR-E64, ZR-E100, ZR-E101, ZR-E102, ZR-E103, ZR-E105, ZR-E106, ZR-E107, ZR-E108, ZR-E109, ZR-100, ZR-101, ZR-102, ZR-103, ZR-105, ZR-106, ZR-107, ZR-108, ZR-109, E100, E101, E102, E103, E105, E106, ZR-M93, ZR-M95, ZR-M96, ZR-M97, ZR-M98, ZR-M99, ZR-M92BT, ZR-M93BT, ZR-M94BT, ZR-M95BT, ZR-M96BT, ZR-M97BT, ZR-G400, ZR- G500, ZR-G600, ZR-G700, ZR-G800, ZR-M902, ZR-M903, ZR-M904, ZR-M905, ZR-M906, ZR-M907, ZR-M908, ZR-M92, E107, E108, E109, Z100, Z101, Z102, Z103, Z105, Z10, Z107, Z108, Z109)

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	2025-04-24
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2022-03-13

Official Correspondent

Hongliang Liu

US Agent Details

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

Related Public Records

Same Entity

Zhongrui HearJoy Medical Equipment 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022507139. Last updated year: 2026. Please use registration number 3022507139 when referencing this establishment in official correspondence.