Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015479927

FEI Number

3015479927

Entity Name

Changzhou CareU Medical Instruments Co., Ltd.

City/State/Country

Changzhou City Jiangsu, CN

Establishment Address

No.69 Shunshan Road, Zhenglu Town, Tianning District, Changzhou City Jiangsu 213000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changzhou CareU Medical Instruments Co., Ltd (Owner Number: 10060446)

Owner / Operator Contact Address

No.69 Shunshan Road, Zhenglu Town, Tianning District, Changzhou City, CN-JS 213000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pediatric Urine Collector Disposable Non-surgical Mask Feeding Bag Plastic Parts Urine Drainage Bag Disposable Sampling Swab, Medical Cotton Swab Leg Bag Paracentesis Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFH	Collector, Urine, Pediatric, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2024-12-30
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-18
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2019-05-13
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2019-05-13
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2024-12-30
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2026-01-19
PYC	Paracentesis Tray	General, Plastic Surgery	Class 1	878.4200	2019-12-31

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Changzhou CareU Medical Instruments 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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Similar Registrations

Registration Number	Establishment Name	Location
3013513837	Tylenol Medical Instruments Co., Ltd.	Zhongshan Guangdong, CN
1825146	Cook Incorporated	Spencer, IN, US
3034669683	HUZHOU JUNDA INDUSTRY CO., LTD.	Anji Zhejiang, CN
3006082230	C.R. BARD, INC.	MADISON, GA, US
3008496560	NINGBO GREETMED MEDICAL INSTRUMENTS CO., LTD.	Ningbo Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015479927. Last updated year: 2026. Please use registration number 3015479927 when referencing this establishment in official correspondence.