TAMPON INNOVATIONS · 89-08 · BULGARIA
For TAMPON INNOVATIONS, import alert is 89-08; country is BULGARIA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Vaginal Microbiome Screening Kits (aka Vaginal Microbiome Test; and Vaginal Sample Collection Kit) | Vaginal Microbiome Screening Kits (aka Vaginal Microbiome Test; and Vaginal Sample Collection Kit); product code is 80 P - - WC General wellness product | 85 H - - EB Tampon, Menstrual, Unscented; date published is 07/17/2025; address is Rozhen 41a, Nadezhda Dist, Bulevard Rozhen 41a , Iliyantsi, Sofia BULGARIA, verified against its source on 2026-09-30.
- Firm
- TAMPON INNOVATIONS verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- BULGARIA verified
- Address
- Rozhen 41a, Nadezhda Dist, Bulevard Rozhen 41a , Iliyantsi, Sofia BULGARIA verified
- Date published
- 07/17/2025 verified
- Product code
- 80 P - - WC General wellness product | 85 H - - EB Tampon, Menstrual, Unscented each item verified
- Product
- Vaginal Microbiome Screening Kits (aka Vaginal Microbiome Test; and Vaginal Sample Collection Kit) | Vaginal Microbiome Screening Kits (aka Vaginal Microbiome Test; and Vaginal Sample Collection Kit) each item verified
What the source says
TAMPON INNOVATIONS Date Published : 07/17/2025 Rozhen 41a, Nadezhda Dist, Bulevard Rozhen 41a , Iliyantsi, Sofia BULGARIA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
80 P - - WC General wellness product Date Published: 08/06/2026 Desc: Vaginal Microbiome Screening Kits (aka Vaginal Microbiome Test; and Vaginal Sample Collection Kit) 85 H - - EB Tampon, Menstrual, Unscented Date Published: 07/17/2025 Desc: Vaginal Microbiome Screening Kits (aka Vaginal Microbiome Test; and Vaginal Sample Collection Kit)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html