Data / Medical devices / Slovenia / TOSAMA d.o.o.
TOSAMA d.o.o.: FDA-registered device maker in Domzale, Slovenia, 2 510(k) clearances
TOSAMA d.o.o. is registered with the FDA (registration 3007740671) in Domzale, Slovenia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 2, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007740671
- Address
- Vir Saranoviceva Cesta 35, Domzale, Slovenia, 1230
- Owner or operator
- TOSAMA d.o.o. (10029863)
- Roles
- Manufacturer
- First device listed
- May 4, 2015
- Registered through
- 2026
- Brand names listed
- External pads, various brands and models, Tosama 100% Cotton Menstrual Tampon, Tosama 100% Organic Cotton Menstrual Tampon
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pad, Menstrual, Unscented | HHD | 1 | Manufacturer | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | 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 |
|---|---|---|---|---|---|---|
| July 2, 2015 | K151170 | Tosama 100% Organic Cotton Menstrual Tampon | HEB | Substantially Equivalent | Tosama, D.O.O. | accessdata.fda.gov |
| April 20, 2015 | K150897 | Tosama 100% Cotton Menstrual Tampon | HEB | Substantially Equivalent | Tosama, D.O.O. | accessdata.fda.gov |
Compare with other makers
Updated July 2, 2015. 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.