Jiangsu Huayuan Medical Technology Co., Ltd.

Manufacturer and brand owner in Dongtai, Jiangsu, China. 1 device type, 1 product catalogued, 2 clearances.

Registry build 21.09.26

Jiangsu Huayuan Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Vinyl Patient Examination Glove. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2019.

1device type
1product
2510(k) clearances

Registration

FDA registration record for Jiangsu Huayuan Medical Technology Co., Ltd.
Registered name JIANGSU HUAYUAN MEDICAL TECHNOLOGY CO., LTD.
Status Registered
Registration expires 2026
Registration number 3012304513
FEI number 3012304513
DUNS 560456236
Establishment type Contract manufacturer, Manufacturer

Chinese Registration

Chinese company register details for Jiangsu Huayuan Medical Technology Co., Ltd.
Chinese legal name 江苏华源医疗科技有限公司
Source Qichacha company register

Location

Address of Jiangsu Huayuan Medical Technology Co., Ltd.
City Dongtai
Province Jiangsu
Address No.36 Nanzhuang Road, High-Tech Industrial Development Zone of
Postal code 224200
Country China

What It Makes

Device types Jiangsu Huayuan Medical Technology Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Vinyl Patient Examination Glove Class 1 Vinyl Patient Examination Gloves 2019 72

Own-Brand Listings

Devices catalogued by Jiangsu Huayuan Medical Technology Co., Ltd.
Product Code Catalogue numbers
Huayuan LYZ 10

Clearances

2 clearances name Jiangsu Huayuan Medical Technology Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Jiangsu Huayuan Medical Technology Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K213044 2022-01-21 LZA Traditional This company
K211045 2021-06-23 LYZ Traditional This company
K102362 2010-10-04 LYZ Traditional Jiangsu Huayuan Gloves Co., Ltd.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Jiangsu Huayuan Medical Technology Co., Ltd.
Main products Vinyl gloves, Nitrile gloves, Disposable PVC gloves, PE gloves
Certifications FDA, CE, ISO 9001, ISO 13485, PPE (SATRA)

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer Device types
Jiangsu Kehua Medical Instrument Technology Co., Ltd. 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer