Scandicare Ab · 89-08 · SWEDEN
For Scandicare Ab · 89-08 · SWEDEN, 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 SWEDEN; 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 2026-09-16.
- 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 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.
— 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.