Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003500682

FEI Number

3003500682

Entity Name

ONTEX CZ S.R.O.

City/State/Country

TURNOV Liberec, CZ

Establishment Address

491, VESECKO, TURNOV Liberec CZ-51101, CZ

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

K090819

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
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2008-07-10
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2012-11-18

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
9617256	ONTEX PENINSULAR SAU	SEGOVIA, ES
3003449471	Ontex Eeklo	Eeklo Oost-Vlaanderen, BE
3012409274	Ontex Manufacturing Italy SRL	Ortona Chieti, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K923985	Personal Products Co.	UNSCENTED MENSTRUAL TAMPON	1993-02-19
K151170	Tosama, D.O.O.	Tosama 100% Organic Cotton Menstrual Tampon	2015-07-02
K930149	Kimberly-Clark Corp.	KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+	1994-03-02

Similar Registrations

Registration Number	Establishment Name	Location
3030979401	Everylife Inc	West Palm Beach, FL, US
3038282948	CORDIS LOGISTICS SP. Z O.O.	Radomsko Lodzkie, PL
3010692191	Ontex BV	Buggenhout Oost-Vlaanderen, BE
3011964664	PROCTER & GAMBLE DISTRIBUTING LLC, THE	Union, OH, US
3014833751	NC - Albaad Fem US	Kernersville, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003500682. Last updated year: 2026. Please use registration number 3003500682 when referencing this establishment in official correspondence.