# VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI · 89-08 · TURKEY — FDA import alert red lists: firms subject to detention without physical examination

For VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI · 89-08 · TURKEY, 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 TURKEY; product is Vivoo Test Strips; product code is 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use; date published is 09/30/2019; address is Teknokent Ari 1 Sit. No: 2 5 15 , Sariyer, Sariyer Istanbul TURKEY, verified against its source on 2026-09-16.

- **Firm:** VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI _(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:** TURKEY _(verified: appears in the quote below)_
- **Address:** Teknokent Ari 1 Sit. No: 2 5 15 , Sariyer, Sariyer Istanbul TURKEY _(verified: appears in the quote below)_
- **Date published:** 09/30/2019 _(verified: appears in the quote below)_
- **Product code:** 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use _(verified: appears in the quote below)_
- **Product:** Vivoo Test Strips _(verified: appears in the quote below)_
- **FDA notes:** Class II device that requires 510(k) clearance _(verified: appears in the quote below)_

## What the source says

> VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI Date Published : 09/30/2019 Teknokent Ari 1 Sit. No: 2 5 15 , Sariyer, Sariyer Istanbul TURKEY 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use Date Published: 09/30/2019 Desc: Vivoo Test Strips Notes: Class II device that requires 510(k) clearance

## 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/).