Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035880570

FEI Number

3035880570

Entity Name

Huizhou Sunwinon Electronics Co. Ltd.

City/State/Country

Huizhou Guangdong, CN

Establishment Address

F 3 of Bldg.9, F 1-4 of Bldg.10, F 3 of Bldg.21, F 1-6 of Bldg.22, Sunwoda Indus Park, Dongpo Ave,, Yuanzhou Town, Boluo County, Huizhou Guangdong 516123, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HONG KONG HUIYUE Technology Co., Limited (Owner Number: 10092473)

Owner / Operator Contact Address

6/F Manulife Place, 348 Kwun Tong Road,, Kowloon, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-01-12
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2025-04-09
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2026-06-08

Official Correspondent

Wu XiaoMin

US Agent Details

CJ frederick Email: cj.frederick@therabodycorp.com Phone: (310) 5708341

Related Public Records

Same Entity

HONG KONG HUIYUE Technology Co., Limited

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3035641506	HONG KONG HUIYUE TECHNOLOGY CO., LIMITED	Kowloon, HK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10

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3030407739	CL MEDIX INC	Chantilly, VA, US
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3025350087	LENYO WORLD LTD	Budapest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035880570. Last updated year: 2026. Please use registration number 3035880570 when referencing this establishment in official correspondence.