# TAMPON INNOVATIONS · 89-08 · BULGARIA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Rozhen 41a, Nadezhda Dist, Bulevard Rozhen 41a , Iliyantsi, Sofia BULGARIA _(verified: appears in the quote below)_
- **Date published:** 07/17/2025 _(verified: appears in the quote below)_
- **Product code:** 80 P - - WC General wellness product | 85 H - - EB Tampon, Menstrual, Unscented _(verified: each item appears in the quote below)_
- **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) _(verified: each item appears in the quote below)_

## 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)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).