VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI · 89-08 · TURKEY
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
- 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
- Address
- Teknokent Ari 1 Sit. No: 2 5 15 , Sariyer, Sariyer Istanbul TURKEY verified
- Date published
- 09/30/2019 verified
- Product code
- 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use verified
- Product
- Vivoo Test Strips verified
- FDA notes
- Class II device that requires 510(k) clearance verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.