Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038193564

FEI Number

3038193564

Entity Name

Fangchenggang shengdong Health Technology Co., Ltd.

City/State/Country

fangchenggangshi Guangxi, CN

Establishment Address

2/F, Building 2, Phase 1, Yunlang Technology Park, intersection of Beibu GulfAvenue and Wenchang Avenue, fangchenggangshi Guangxi 538021, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fangchenggang shengdong Health Technology Co., Ltd. (Owner Number: 10092980)

Owner / Operator Contact Address

2/F, Building 2, Phase 1, Yunlang Technology Park, intersection of Beibu GulfAvenue and Wenchang Avenue, Fangchenggangshi, CN-GX 538021, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Heard Aids(Model:BH-R55-07,BH-55-01,BH-55-02,BH-55-03,BH-55-04,BH-55-05,BH-55-06,BH-55-07) Heard Aids(Model:MBH-R55-01,BH-R55-02,BH-R55-03,BH-R55-04,BH-R55-05,BH-R55-06 ) Heard Aids(Model:BH-R56-01,BH-R56-02,BH-R56-03,BH-R56-04,BH-R56-05,BH-R56-06,BH-R56-07 ) Heard Aids(Model:BH-T45-01,BH-T45-02,BH-T45-03,,BH-T45-04,BH-T45-05,BH-T45-06, BH-T45-07) Heard Aids(Model:N-35-01,N-35-02,N-35-03) Hearing Aids(model:BHR55-01)

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	2025-03-12
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2026-03-19

Official Correspondent

Xiaojing Wang

US Agent Details

Maple Chen Business: GVM Medical LLC Email: info@gvmmedical.com Phone: (610) 4517988

Related Public Records

Same Entity

Fangchenggang shengdong Health Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3014144866	OLIVE UNION INC.	Seocho-Gu Seoul, KR
3017827954	BestNews Electronic Ware(S.Z) CO.,LTD	ShenZhen Guangdong, CN
3029745674	ISUNIYE LLC	Milpitas, CA, US
3030682076	ELEHEAR INC.	Shenzhen Guangdong, CN
3035551790	Audicus	New York, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038193564. Last updated year: 2026. Please use registration number 3038193564 when referencing this establishment in official correspondence.