Scandicare Ab · 89-08 · SWEDEN
For Scandicare Ab, import alert is 89-08; country is SWEDEN; 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 code is 79 H - - XD Clamp | 85 H - - FW Clamp, Umbilical; date published is 09/16/2009; address is Box 24 (Agatan 7) , Anderstorp, SWEDEN, verified against its source on 2026-09-30.
- Firm
- Scandicare Ab 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
- SWEDEN verified
- Address
- Box 24 (Agatan 7) , Anderstorp, SWEDEN verified
- Date published
- 09/16/2009 verified
- Product code
- 79 H - - XD Clamp | 85 H - - FW Clamp, Umbilical each item verified
- FDA notes
- All devices 11/21/1995 DWI = DE | 11/21/1995 All devices DWI = DE. each item verified
What the source says
Scandicare Ab Date Published : 09/16/2009 Box 24 (Agatan 7) , Anderstorp, SWEDEN
— 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 and FDA notes
79 H - - XD Clamp Date Published: 09/16/2009 Notes: All devices 11/21/1995 DWI = DE 85 H - - FW Clamp, Umbilical Date Published: 09/16/2009 Notes: 11/21/1995 All devices DWI = DE.
— 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.