# Orion Versand Gmbh & Co. · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For Orion Versand Gmbh & Co. · 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 Breast Pump; product code is 85 H - - GX Pump, Breast, Powered; date published is 07/14/2010; address is Schaferweg 14 , Flensburg, Schleswig-Holstein GERMANY, verified against its source on 2026-09-16.

- **Firm:** Orion Versand Gmbh & Co. _(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:** Schaferweg 14 , Flensburg, Schleswig-Holstein GERMANY _(verified: appears in the quote below)_
- **Date published:** 07/14/2010 _(verified: appears in the quote below)_
- **Product code:** 85 H - - GX Pump, Breast, Powered _(verified: appears in the quote below)_
- **Product:** Breast Pump _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Orion Versand Gmbh & Co. Date Published : 07/14/2010 Schaferweg 14 , Flensburg, Schleswig-Holstein GERMANY 85 H - - GX Pump, Breast, Powered Date Published: 07/14/2010 Desc: Breast Pump Notes: Class II

## 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/).