Data / Medical devices / Czechia / Ontex CZ S.R.O.
Ontex CZ S.R.O.: FDA-registered device maker in TURNOV Liberec, Czechia, 3 510(k) clearances
Ontex CZ S.R.O. is registered with the FDA (registration 3003500682) in TURNOV Liberec, Czechia. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated December 23, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003500682
- Address
- 491, Vesecko, TURNOV Liberec, Czechia, CZ-51101
- Owner or operator
- Ontex BV (9036701)
- Roles
- Exporter to the US
- First device listed
- July 10, 2008
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 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
Updated December 23, 2009. 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.