Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012409274

FEI Number

3012409274

Entity Name

Ontex Manufacturing Italy SRL

City/State/Country

Ortona Chieti, IT

Establishment Address

Zona Industriale Cap, Localita' Cucullo, Ortona Chieti 66026, IT

Establishment Type(s)

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

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
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2006-09-21
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2003-02-27

Official Correspondent

Cecilia Guadalupe Jimenez Rodriguez

US Agent Details

Kyna Smith Business: Valor Brands LLC Email: kyna.smith@ontexglobal.com Phone: (770) 3469250

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

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3016654531	SEKHANI INDUSTRIES PVT LTD	Ahmedabad Gujarat, IN
9615625	KIMBERLY-CLARK PERSONAL HYGIENIC PRODUCTS CO.,LTD.BEIJING	DEVELOPMENT ZONE, BEIJING, CN
3017366514	FIBRIL TEX PVT LTD.	Amritsar Punjab, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012409274. Last updated year: 2026. Please use registration number 3012409274 when referencing this establishment in official correspondence.