SHAOGUAN REGENEX PHARMACEUTICAL CO., LTD.

FDA Device Registration & Listing · Shaoguan Guangdong, CN · Registration 3042262517

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042262517
FEI Number
3042262517
Entity Name
SHAOGUAN REGENEX PHARMACEUTICAL CO., LTD.
City/State/Country
Shaoguan Guangdong, CN
Establishment Address
No.9, Gantang Ninth Road, Gantang Avenue, Wujiang District,, Shaoguan Guangdong 512029, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shaoguan Regenex Pharmaceutical Co., Ltd. (Owner Number: 10094273)
Owner / Operator Contact Address
No.9, Gantang Ninth Road, Gantang Avenue, Wujiang District,, Shaoguan, CN-GD 512029, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250034
PMA Number
N/A

All Registered Proprietary Names

Natural Rubber Latex Male Condom

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HIS Condom Obstetrics/Gynecology Class 2 884.5300 2025-11-20

Official Correspondent

Kangwei Pan

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shaoguan Regenex Pharmaceutical Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042262517. Last updated year: 2026. Please use registration number 3042262517 when referencing this establishment in official correspondence.
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