Data / Medical devices / Bulgaria / Tampon Innovations
Tampon Innovations: FDA-registered device maker in Sofia Sofia-Grad, Bulgaria, 1 510(k) clearance
Tampon Innovations is registered with the FDA (registration 3028725772) in Sofia Sofia-Grad, Bulgaria. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 18, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3028725772
- Address
- 41A Rozhen Blvd, Sofia Sofia-Grad, Bulgaria, 1271
- Owner or operator
- Daye (Anne's Day Ltd) (10088636)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- September 11, 2023
- Registered through
- 2026
- Brand names listed
- Daye Hemp Pads, Daye Organic Tampons, Daye Vaginal Tampon Swab, Daye at-Home Microbiome Screening, Daye at-Home Vaginal Microbiome Screen, Vaginal Microbiome Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| August 18, 2023 | K223883 | Daye Tampon | HEB | Substantially Equivalent | Annes Daye, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Pad, Menstrual, Unscented
- All makers of Tampon, Menstrual, Unscented
Updated August 18, 2023. 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.