Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007165189

FEI Number

3007165189

Entity Name

UNISOURCE SHANGHAI LTD.

City/State/Country

SHANGHAI, CN

Establishment Address

Bldg.#2, ROOM 802 Huayi Building, No.2020 Zhongshan Road West, Shanghai 200235 China, SHANGHAI 200235, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Unisource Shanghai Ltd. (Owner Number: 10027023)

Owner / Operator Contact Address

Room 1416 Fortune Times Square,, No.1438 North Sanxi Road, Putuo Dist.,, Shanghai, CN-SH 200060, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mouth Mate Comfort Soft Large Tongue-Guide Standard Pro Comfort Soft Small Tongue-Guide Infant Home Tongue-Guide Infant Pro Shoecovers, Overshoes Dental Wax Orthodontic Wax Bouffant Caps, Mop Caps, Doctor Caps, Dental Floss Accessory, Surgical Apparel - Non-woven Face Masks Teeth Whitening Strips Refill-Ease Lock N Reload LED Headlight System Face Masks, 3 Layer Flat Angle-Ease Ejector Toothbrush Sanitizer Toothbrushes Adult & Kids Toothbrush Powered, Eletricity Toothbrush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIG	Retractor, All Types	Dental	Class 1	872.4565	2025-12-11
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-07-29
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2021-03-09
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-07-29
JES	Floss, Dental	Dental	Class 1	872.6390	2008-09-17
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-24
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2023-07-29
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2025-09-17
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2023-05-09
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2010-06-17
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2026-05-02
NOB	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	Dental	Class 1	872.6855	2023-05-31
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2016-01-12
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2008-09-17
EFN	Cotton, Roll	Dental	Class 1	872.6050	2012-05-23
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2023-04-09

Official Correspondent

Julia Wu

US Agent Details

william slevin Business: medapproval llc Email: qara@medapprovalllc.com Phone: (404) 5935005

Related Public Records

Same Entity

Unisource Shanghai 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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Similar Registrations

Registration Number	Establishment Name	Location
3014647261	RETRACT EEZ, INC.	Largo, FL, US
3033892080	TALENT TECHNOLOGY MOULD CO., LIMITED	Shenzhen Guangdong, CN
1315756	Weco Manufacturing Group-Henrietta	Rochester, NY, US
3036269993	GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD	Nanning Guangxi, CN
3011585752	HANGZHOU HAIZHU MIM PRODUCTS CO., LTD	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007165189. Last updated year: 2026. Please use registration number 3007165189 when referencing this establishment in official correspondence.