# Tecsana Gmbh · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** GERMANY _(verified: appears in the quote below)_
- **Address:** Planegger Str. 9a , Munich, Bavaria GERMANY _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 85 H - - DN Dilator, Cervical, Expandable _(verified: appears in the quote below)_
- **Product:** Epi-No Delphine Trainer Plus _(verified: appears in the quote below)_
- **FDA notes:** 9/13/2006 _(verified: appears in the quote below)_

## 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

## 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/).