TAMPON INNOVATIONS · 89-08 · BULGARIA
For TAMPON INNOVATIONS · 89-08 · BULGARIA, import alert is 89-08; 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)"; country is BULGARIA; 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 2026-09-16.
- 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 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)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html