Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031190571

FEI Number

3031190571

Entity Name

Primecare Medical (Huzhou) Co.,Ltd.

City/State/Country

Hu zhou Zhejiang, CN

Establishment Address

No. 398 Guang Yuan Road, Wu Xing District, 313099 Huzhou, PEOPLE'S REPUBLIC OF CHINA, Hu zhou Zhejiang 313099, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Primecare Medical(Huzhou) Co.,Ltd. (Owner Number: 10090438)

Owner / Operator Contact Address

No. 398 Guang Yuan Road, Wu Xing District, 313099 Huzhou, PEOPLE'S REPUBLIC OF CHINA, Hu zhou, CN-ZJ 313099, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Suction connecting tube Extension tube BAG, URINARY DRAIN Urinary drainage Bag Holder Prefilled Syringe Lub Jelly Syringe Extension Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2024-07-24
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2024-07-24
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-03-27
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2024-07-25
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2024-08-02

Official Correspondent

Juan Wu

US Agent Details

Wei Zhang Business: 3dstocking Inc Email: ge@3dstocking.com Phone: (772) 9996108

Related Public Records

Same Entity

Primecare Medical(Huzhou) 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
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26

Similar Registrations

Registration Number	Establishment Name	Location
3030413693	Medway Supplies Inc	Lake Elsinore, CA, US
1062154	NDH MEDICAL, INC.	Saint Petersburg, FL, US
3010594263	JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD.	Shuyang Jiangsu, CN
3015967359	Stryker Instruments	Portage, MI, US
3003902679	ENTER MEDICAL CORPORATION	Chiayi County, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031190571. Last updated year: 2026. Please use registration number 3031190571 when referencing this establishment in official correspondence.