Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002993863

FEI Number

3002993863

Entity Name

Shaoxing Fuqing Health Products Co., Ltd.

City/State/Country

Shaoxing Zhejiang, CN

Establishment Address

No. 599 Wuxie Road, Shaoxing High-Tech Industrial Development Zone, No. 79 Zhongshan Road, Yuecheng District,, Shaoxing Zhejiang 312000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shaoxing Fuqing Health Products Co., Ltd. (Owner Number: 10038000)

Owner / Operator Contact Address

No. 599 Wuxie Road, Shaoxing High-Tech, Industrial Development Zone,, Shaoxing, CN-ZJ 312000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CATHETER MALE POCKET16"STRTIP14KIT 30 US (M14UK) CATHETER MALE HYDRPC16"STRTIP14KIT 30 US (HM14UK) CATHETER INSERTION W/UCONN KIT (90PK)US (K2-90) CATHETER MALE HYDRPC16"STRTIP12KIT 30 US (HM12UK) CATHETER INSERTION W/DISPOSAL BAG KIT US (K1) CATHETER MALE HYDRPC16"STRTIP16KIT 30 US (HM16UK) Twist Catheter with Insertion Kit Cure Medical Catheter with Insertion Kit, Model HMxxUK Hydrophilic Coated Cure Catheter With Insertion Kit Cure Medical Catheter Insertion Kit, Model K1 Cure Medical Catheter with Insertion Kit, Model M14UK Cure Medical Catheter Insertion Kit, Model K2 T12K Cure Twist Female 12 Catheter Kit with Supplies T10K Cure Twist Female 10 Catheter Kit with Supplies T16K Cure Twist Female 16 Catheter Kit with Supplies T8K Cure Twist Female 8 Catheter Kit with Supplies T14K Cure Twist Female 14 Catheter Kit with Supplies

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2025-06-11
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2011-09-05
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2026-01-21

Official Correspondent

Dean Wu

US Agent Details

Charles Shen Business: Manton Business and Technology Services Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

Shaoxing Fuqing Health Products Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

Similar Registrations

Registration Number	Establishment Name	Location
3018116884	ROZER STERILIZATION TECHNOLOGY SHUYANG COMPANY LIMITED	Shuyang Jiangsu, CN
3011987967	ConvaTec, Inc.	Greensboro, NC, US
3005669815	AMSINO MEDICAL (KUNSHAN) CO., LTD.	KUNSHAN CITY Jiangsu, CN
3017961114	SUZHOU PROSTERI MEDICAL TECHNOLOGY CO., LTD.	Suzhou Jiangsu, CN
3015176887	GREYSTONE MEDICAL, LLC	Waterford, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002993863. Last updated year: 2026. Please use registration number 3002993863 when referencing this establishment in official correspondence.