Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038319740

FEI Number

3038319740

Entity Name

GUANGDONG YUXIANG SILICONE & PLASTIC CO.,LTD

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

4th Floor of Building 1,1st Floor to 4th Floor of Building 2, No.8,Kejian Street,Fusha Town, Zhongshan Guangdong 528400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GuangDong YuXiang Silicone & Plastic Co.,Ltd (Owner Number: 10093352)

Owner / Operator Contact Address

4th Floor of Building 1,1st Floor to 4th Floor of Building 2, No.8,Kejian Street,Fusha Town, Zhongshan, CN-GD 528400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241748

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIR	Perineometer	Obstetrics/Gynecology	Class 2	884.1425	2025-05-05
HDX	Dilator, Vaginal	Obstetrics/Gynecology	Class 2	884.3900	2025-05-05
HDX	Dilator, Vaginal	Obstetrics/Gynecology	Class 2	884.3900	2025-05-05

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

GuangDong YuXiang Silicone & Plastic 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 3038319740. Last updated year: 2026. Please use registration number 3038319740 when referencing this establishment in official correspondence.