Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016965811

FEI Number

3016965811

Entity Name

SHANGHAI SUNWIN INDUSTRY GROUP CO.,LTD.

City/State/Country

Shanghai, CN

Establishment Address

NO.17, Lane 688 Hengnan Road, Minghang District, Shanghai 201112, CN

Establishment Type(s)

Reprocess Single-Use Device

Owner / Operator

Shanghai Sunwin Industry Group Co., Ltd. (Owner Number: 10065587)

Owner / Operator Contact Address

No.17, Lane 688 Hengnan Road, Minghang District, Shanghai, CN-NOTA 201112, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

UP&UP Glove SMG Isolation Coverall SWGI Hand sanitizer SWH Cooling Comforter UP&UP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2022-09-27
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-29
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-29
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2020-03-29
PWC	General Wellness Product	Unknown	Class N	N/A	2024-03-08
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-09-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Shanghai Sunwin Industry Group 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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Similar Registrations

Registration Number	Establishment Name	Location
3005423373	TRI-FI KNITTING, LLC	Dunlap, TN, US
3008973900	SAFECARE MEDICAL PRODUCTS CO., LTD. (HEFEI)	HEFEI Anhui, CN
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3015414796	COMPRESS INNOVATIONS, LLC	Manhasset, NY, US
3004651767	CLEARPOINT MEDICAL	Lachine Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016965811. Last updated year: 2026. Please use registration number 3016965811 when referencing this establishment in official correspondence.