Data / Medical devices / Belgium / Ontex BV
Ontex BV: FDA-registered device maker in Buggenhout Oost-Vlaanderen, Belgium, 8 510(k) clearances
Ontex BV is registered with the FDA (registration 3010692191) in Buggenhout Oost-Vlaanderen, Belgium. It lists 3 device types. 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
- 3010692191
- Address
- 5 Genthof, Buggenhout Oost-Vlaanderen, Belgium, B-9255
- Owner or operator
- Ontex BV (9036701)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- February 27, 2003
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Garment, Protective, For Incontinence | EYQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Exporter to the US | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Exporter to the US | 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
- All makers of Garment, Protective, For Incontinence
- All makers of Pad, 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.