Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018520804

FEI Number

3018520804

Entity Name

ZHONGSHAN SUNCLEAN CO.,LTD

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

F/5, F/6 #1, F/7, F/8 #2 & F/9,Building G, NO.3 of Huanzhen North 13 RD, Henglan Town, Zhongshan, Guangdong, Zhongshan Guangdong 528478, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhongshan Sunclean Co.,Ltd (Owner Number: 10083364)

Owner / Operator Contact Address

F/5, F/6 #1, F/7, F/8 #2 & F/9,Building G, NO.3 of Huanzhen North 13 RD, Henglan Town, Zhongshan, Guangdong, Zhongshan, CN-GD 528478, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

UVC LED Sterilizing Box,SZH40-T5,SZH40-T5BAT,SZH500-T6 59S SUNCLEAN LIGHTING 3-IN-1 LED Panel Light,SZS18-P10-6060,SZS24-P10-6060B,SZS18-P 10-30120,SZS36-P10-30130 59S SUNCLEAN LIGHTING 3-IN-1 LED Panel Light,SZS18-P10-60120 59S SUNCLEAN LIGHTING 3-IN-1 LED Downlight,SZS6-D20-4,SZS6-D20-4S,SZS6-D20-5,SZS8-D20-6,SZS9-D20-8 59S UV-C LED Air Sanitizer Bar,SZS60-X50,SZS20-X51,SZS20-X55 UVLED Multi-function Sterilizer Lid,SZQ5-S8BAT 59S SUNCLEAN LIGHTING 3-IN-1 LED Downlight,SZS9-D40-25,SZS9-D20-3,SZS9-D40-3,SZS9-D20-25S,SZS6-D20-25 59S SUNCLEAN LIGHTING 3-IN-1 LED Downlight,SZS16-D30-16,SZS25-D30-25,SZS25-X20, SZS25-X30,SZS25-X33 Automatic Space Sterilizer,SZS30-SUN1 59S Instant Disinfection Fixture,L1000,L2000 59S SUNCLEAN LIGHTING 3-IN-1 LED Downlight,SZS16-D10-6,SZS18-D10-8,SZS12-D10-4U,SZS12-D10-6U,SZS9-D20-25 59S SUNCLEAN LIGHTING 3-IN-1 LED Panel Light,SZS12-P10-3030,SZS16-P10-3030B,SZS12-P10-3060,SZS16-P10-3060B UVC LED Sterilizing Box,SZH500-T6,SZH500-T5,T5PRO 59S UV-C LED Sterilization Cabinet,M5000,M5000A,M5000B,M5000C

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEC	Disinfector, Medical Devices	General Hospital	Class 2	880.6992	2023-05-03

Official Correspondent

Wulin Wei

US Agent Details

Chow Kiki Email: Azur-a@outlook.com Phone: (303) 4370886

Related Public Records

Same Entity

Zhongshan Sunclean Co.,Ltd

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2026	Getinge Disinfection Ab Ljungadalsgatan	2	Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Z-0018-2014	Getinge Disinfection Ljungadalsgatan	2	Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

Similar Registrations

Registration Number	Establishment Name	Location
3012006473	REHABILITATION EQUIPMENT ASSOCIATES, INC	Manchester, NH, US
3005544459	STEELCO S.P.A.	Riese Pio X Treviso, IT
8021896	ALBERT BROWNE LTD.	LEICESTER, GB
3017293064	XIAMEN FORSOUND HEARING TECHNOLOGY CO.,LTD.	Xiamen Fujian, CN
3027509245	AOPU LIGHTING (JINYUN) CO., LTD.	Lishui Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018520804. Last updated year: 2026. Please use registration number 3018520804 when referencing this establishment in official correspondence.