Orion Versand Gmbh & Co. · 89-08 · GERMANY
For Orion Versand Gmbh & Co., 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 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 2026-09-30.
- Firm
- Orion Versand Gmbh & Co. 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
- Schaferweg 14 , Flensburg, Schleswig-Holstein GERMANY verified
- Date published
- 07/14/2010 verified
- Product code
- 85 H - - GX Pump, Breast, Powered verified
- Product
- Breast Pump verified
- FDA notes
- Class II verified
What the source says
Orion Versand Gmbh & Co. Date Published : 07/14/2010 Schaferweg 14 , Flensburg, Schleswig-Holstein 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 - - GX Pump, Breast, Powered Date Published: 07/14/2010 Desc: Breast Pump Notes: Class II
— 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.