Data / Medical devices / Germany / Ontex Hygieneartikel Deutschland GMBH

Ontex Hygieneartikel Deutschland GMBH: FDA-registered device maker in GROSSPOSTWITZ Saxony, Germany, 8 510(k) clearances

Name: Ontex Hygieneartikel Deutschland GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ontex Hygieneartikel Deutschland GMBH is registered with the FDA (registration 9615100) in GROSSPOSTWITZ Saxony, Germany. It lists 1 device type. The FDA files 8 510(k) clearances under its listings, the newest dated December 20, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9615100
FEI number: 3001019699
Address: Fabrikstrasse 30, GROSSPOSTWITZ Saxony, Germany, 02692
Owner or operator: Ontex BV (9036701)
Roles: Contract manufacturer, Manufacturer
First device listed: July 10, 2008
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Tampon, Menstrual, Unscented	HEB	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 20, 2019	K191666	Unscented W long plastic and cardboard applicator tampons	HEB	Substantially Equivalent	Ontex Bvba	accessdata.fda.gov
March 3, 2017	K162746	Ontex and other proprietary names	HEB	Substantially Equivalent	Ontex Bvba	accessdata.fda.gov
June 23, 2015	K142786	Ontex Unscented Tampons with Colored Plastic Applicators	HEB	Substantially Equivalent	Ontex Bvba	accessdata.fda.gov
April 23, 2014	K132595	ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS	HEB	Substantially Equivalent	Ontex Bvba	accessdata.fda.gov
December 19, 2012	K122603	ONTEX AND OTHER PROPRIETARY NAMES	HEB	Substantially Equivalent	Ontex Bvba	accessdata.fda.gov
December 23, 2009	K090819	ONTEX TAMPON (UNSCENTED)	HEB	Substantially Equivalent	Ontex International NV	accessdata.fda.gov
January 25, 1996	K954942	NATRACAREN APPLICATOR TAMPON	HEB	Substantially Equivalent	Bodywise (Uk), Ltd.	accessdata.fda.gov
September 3, 1993	K914430	NATRACARE TAMPON	HEB	Substantially Equivalent	Bodywise (Uk), Ltd.	accessdata.fda.gov

Compare with other makers

All makers of Tampon, Menstrual, Unscented

Updated December 20, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.