Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016884033

FEI Number

3016884033

Entity Name

UCOMFOR SCIENTIFIC CO.,LTD

City/State/Country

Zhangjiagang Jiangsu, CN

Establishment Address

Lekun Road, Leyu Town, Zhangjiagang Jiangsu 215621, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ucomfor Scientific Co.,Ltd (Owner Number: 10067128)

Owner / Operator Contact Address

Lekun Road, Leyu Town, Zhangjiagang, CN-JS 215621, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Drainage bags Urinary drainage bag 500cc-2000cc , Urinary Leg bag, Drainage Bag Connector Vaginal Speculum Surgical face mask SUCTION YANKAUER, Yankauer, non-vented bulb/regular tip, Sterile,Yankauer, vented bulb/regular tip Suct instr yank blb w/o vent, Yankauer, vented regular tip, Sterile, Latex Free, Suct instr yank reg w vent Vaginal speculum Thumb control piston irrigation syringe 60cc ST, Bulb irrigation syringe 60cc ST, Flat top piston irrigation syringe 60c Urine meters TUBE, ASPIRATING, FLEXIBLE, CONNECTING, Suction conneting tube, Suction Tubing Mask, Scavenging Face Mask Feeding tubes, Nasoenteric Feeding Tubes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	2021-03-29
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2021-12-23
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2022-01-27
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2022-05-19
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-03
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2021-12-23
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2021-12-23
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2021-12-23
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2021-12-23
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2021-12-23
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-04-15
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-03
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2025-07-23

Official Correspondent

Ava Wu

US Agent Details

James St. WU Business: Humiss Inc. Email: cc401vip@126.com Phone: (720) 7595888

Related Public Records

Same Entity

Ucomfor Scientific 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
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3003903031	WELL LEAD MEDICAL CO. LTD	GUANGZHOU Guangdong, CN
8010418	HENKE-SASS WOLF, GMBH.	TUTTLINGEN Baden-Wurttemberg, DE
3011106828	TECMA OPERACIONES S. DE R.L. DE C.V.	Juarez Chihuahua, MX
9610711	COLOPLAST MANUFACTURING FRANCE, SAS	Sarlat la Caneda Cedex Dordogne, FR
1828132	BOSTON SCIENTIFIC CORPORATION	SPENCER, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016884033. Last updated year: 2026. Please use registration number 3016884033 when referencing this establishment in official correspondence.