Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009104075

FEI Number

3009104075

Entity Name

UCOMFOR MEDICAL CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

Rm1208, No.76 Jiuxin Road , Shanghai, 201615, P.R.China, Shanghai 201615, CN

Establishment Type(s)

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

Owner / Operator

Ucomfor Medical Co., Ltd. (Owner Number: 10038509)

Owner / Operator Contact Address

Rm1208, No.76 Jiuxin Road , Shanghai, 201615, P.R.China, Shanghai, CN-SH 201615, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Leg Bag Bulb irrigation syringe 60cc, Enteral irrigation syringe 60cc, EAR BULB SYRINGE, Piston enteral irrigation syringe 60cc Urine collector pediatric st, Urine Collector Sterile, Latex Free APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE Urine collector pediatric 100ml SUCTION YANKAUER with/without vent Suction Yankauer, non-vented bulb tip, Sterile; Yankauer, non-vented regular tip, Sterile Suction Tubing, Suction Connection Tubing Connector, catheter Urinary leg bag Urinary drainage bag, DRAINAGE BAG Irrigation syringe,Syringe Ear Ulcer enema bag Surgical Respirator, Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2011-10-20
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2011-10-19
EXI	Device, Paste-On For Incontinence, Sterile	Gastroenterology, Urology	Class 1	876.5250	2011-10-20
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2011-10-19
NOA	Device, Paste-On For Incontinence, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2011-10-20
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2011-10-19
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2011-10-20
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2011-10-20
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2011-10-20
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2011-10-20
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2013-04-03
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-12

Official Correspondent

ZHENGYANG YI

US Agent Details

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

Related Public Records

Same Entity

Ucomfor Medical 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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
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-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

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3014498861	ATOM HEALTH CORPORATION	Tainan City, TW
3016426851	ANHUI ARES MEDICAL TECHNOLOGY CO.,LTD.	Tianchang Anhui, CN
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009104075. Last updated year: 2026. Please use registration number 3009104075 when referencing this establishment in official correspondence.