Ontex BV

FDA Device Registration & Listing · Buggenhout Oost-Vlaanderen, BE · Registration 3010692191

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010692191
FEI Number
3010692191
Entity Name
Ontex BV
City/State/Country
Buggenhout Oost-Vlaanderen, BE
Establishment Address
5 Genthof, Buggenhout Oost-Vlaanderen B-9255, BE
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
N
Expiration Date (Year)
2026
510(k) Number
K122603
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
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
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2020-02-17
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2015-07-13
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2017-11-09
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2013-08-06

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
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
K823241 Kimberly-Clark Corp. NEW FREEDOM THIN UNSCENTED MAXI PADS 1982-12-28

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010692191. Last updated year: 2026. Please use registration number 3010692191 when referencing this establishment in official correspondence.
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