Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019805289

FEI Number

3019805289

Entity Name

Guangdong Health Tree Medical Technology Co., Ltd.

City/State/Country

Zhuhai Guangdong, CN

Establishment Address

Unit 2&4, 5F, Building 2, Production And Processing Center, No.1, Software Park Road, Tangjiawan Town, High-Te, Zhuhai City, Guangdong Province, Zhuhai Guangdong 519085, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangdong HealthTree Medical Technology Co., Ltd. (Owner Number: 10082184)

Owner / Operator Contact Address

Unit 2&4, 5F, Building 2, Production and Processing Center, No.1, Software Park Road, Tangjiawan Town, High-te, Zhuhai City, Guangdong Province, Zhuhai, CN-GD 519085, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hearing aids; Hearing aids JKS60A; Hearing aids JKS60B; Hearing aids JKS60E; Hearing aids JKS60G JKS50A; JKS50B; JKS50C; JKS50D; JKS50F; JKS50G; JKS50E; JKS50BL;JKS50CL oximeter

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	2024-08-05
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2021-06-24

Official Correspondent

Dong Li

US Agent Details

Cancan Huang Business: OSMUNDA TECHNOLOGY CO., LTD. Email: sunny.huang@osmundacn.com Phone: (858) 3571157

Related Public Records

Same Entity

Guangdong HealthTree Medical 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 3019805289. Last updated year: 2026. Please use registration number 3019805289 when referencing this establishment in official correspondence.