Tecsana Gmbh · 89-08 · GERMANY
For Tecsana Gmbh · 89-08 · GERMANY, 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 GERMANY; product is Epi-No Delphine Trainer Plus; product code is 85 H - - DN Dilator, Cervical, Expandable; date published is 09/16/2009; address is Planegger Str. 9a , Munich, Bavaria GERMANY, verified against its source on 2026-09-16.
- Firm
- Tecsana Gmbh 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
- GERMANY verified
- Address
- Planegger Str. 9a , Munich, Bavaria GERMANY verified
- Date published
- 09/16/2009 verified
- Product code
- 85 H - - DN Dilator, Cervical, Expandable verified
- Product
- Epi-No Delphine Trainer Plus verified
- FDA notes
- 9/13/2006 verified
What the source says
Tecsana Gmbh Date Published : 09/16/2009 Planegger Str. 9a , Munich, Bavaria GERMANY 85 H - - DN Dilator, Cervical, Expandable Date Published: 09/06/2024 Desc: Epi-No Delphine Trainer Plus Notes: 9/13/2006
— 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.