Tecsana Gmbh · 89-08 · GERMANY
For Tecsana Gmbh, import alert is 89-08; country is GERMANY; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
85 H - - DN Dilator, Cervical, Expandable Date Published: 09/06/2024 Desc: Epi-No Delphine Trainer Plus Notes: 9/13/2006
— all from 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.