Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611836

FEI Number

3002807127

Entity Name

Guangzhou Double One Latex Products Co., Ltd.

City/State/Country

GUANGZHOU CITY Guangdong, CN

Establishment Address

South Area of 3# Rubber Road, Chini Town, Huadu District, GUANGZHOU CITY Guangdong 510830, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Guangzhou Double One Latex Products Co., Ltd. (Owner Number: 8043106)

Owner / Operator Contact Address

South Area of 3# Rubber Road, Chini Town, Huadu District, Guangzhou City, CN-GD 510830, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K896142

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
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2007-11-20

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

Guangzhou Double One Latex Products 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 9611836. Last updated year: 2026. Please use registration number 9611836 when referencing this establishment in official correspondence.