Shaoguan Regenex Pharmaceutical Co., Ltd.

Manufacturer and brand owner in Shaoguan, Guangdong, China. 1 device type, 2 products catalogued.

Registry build 21.09.26

Shaoguan Regenex Pharmaceutical Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Condom. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2025.

1device type
2products catalogued under its own name

Registration

FDA registration record for Shaoguan Regenex Pharmaceutical Co., Ltd.
Registered name SHAOGUAN REGENEX PHARMACEUTICAL CO., LTD.
Status Registered
Registration expires 2026
Registration number 3042262517
FEI number 3042262517
DUNS 710872591
Establishment type Manufacturer

Location

Address of Shaoguan Regenex Pharmaceutical Co., Ltd.
City Shaoguan
Province Guangdong
Address No.9, Gantang Ninth Road, Gantang Avenue, Wujiang District,
Postal code 512029
Country China

What It Makes

Device types Shaoguan Regenex Pharmaceutical Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Condom Class 2 Natural Rubber Latex Male Condom 2025 9

Own-Brand Listings

Devices catalogued by Shaoguan Regenex Pharmaceutical Co., Ltd.
Product Code Catalogue numbers
Zioxx Natural Rubber Latex Male Condom HIS 4
Zl0XX(003) Natural Rubber Latex Male Condom HIS 1

Clearances

No clearance names Shaoguan Regenex Pharmaceutical Co., Ltd. as applicant. One 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 Shaoguan Regenex Pharmaceutical Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K250034 2025-07-11 HIS Traditional Shaoguan Regenex Pharmaceuticals Co., Ltd.

From the Company

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

Information published by Shaoguan Regenex Pharmaceutical Co., Ltd.
Founded 2003
Employees 600
Factory area 26362
Main products Reproductive health products, OTC pharmaceuticals, Medical devices, IVD testing

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer Device types
Wing Keung Optical Manufacturing Ltd 2
Shaoguan Guanghua Plastic AND Hardwear Products Ltd 2

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