Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019545200

FEI Number

3019545200

Entity Name

Ontex Operations USA, LLC

City/State/Country

Stokesdale, NC, US

Establishment Address

9300 NC HWY 65, Stokesdale, NC 27357, US

Establishment Type(s)

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

Owner / Operator

Ontex Mexico Operations S.A de C.V (Owner Number: 9036701)

Owner / Operator Contact Address

Calle Doce Norte 105, Ciudad Industrial, Tijuana, MX-BCN 22444, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2003-02-27
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2006-09-21
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-08-11
NRC	Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile	Obstetrics/Gynecology	Class 1	884.5425	2020-08-11

Official Correspondent

Cecilia Guadalupe Jimenez Rodriguez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ontex Mexico Operations S.A de C.V

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010220314	ONTEX MEXICO OPERATIONS SA DE CV	Tijuana Baja California, MX
3013684440	Ontex Sante France SAS	Dourges Hauts-de-France, FR
3003500682	ONTEX CZ S.R.O.	TURNOV Liberec, CZ
9617256	ONTEX PENINSULAR SAU	SEGOVIA, ES
3003449471	Ontex Eeklo	Eeklo Oost-Vlaanderen, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28

Similar Registrations

Registration Number	Establishment Name	Location
3032900656	CAREWELL FAMILY, INC	Coral Gables, FL, US
3011446173	FISCHER MANUFACTURING LLC	Fairfield, OH, US
3010048541	ABENA NORTH AMERICA, INC.	Oceanside, CA, US
3016452317	GUANGDONG CHUANTIAN SANITARY PRODUCTS CO.,LTD	Zhongshan Guangdong, CN
3012162353	INTELLIGENT FABRIC TECHNOLOGIES (NORTH AMERICA) INC.	Markham Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019545200. Last updated year: 2026. Please use registration number 3019545200 when referencing this establishment in official correspondence.