Orion Versand Gmbh & Co. · 89-08 · GERMANY
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
- 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 85 H - - GX Pump, Breast, Powered Date Published: 07/14/2010 Desc: Breast Pump Notes: Class II
— 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.