# Scandicare Ab · 89-08 · SWEDEN — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** SWEDEN _(verified: appears in the quote below)_
- **Address:** Box 24 (Agatan 7) , Anderstorp, SWEDEN _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 79 H - - XD Clamp | 85 H - - FW Clamp, Umbilical _(verified: each item appears in the quote below)_
- **FDA notes:** All devices 11/21/1995 DWI = DE | 11/21/1995 All devices DWI = DE. _(verified: each item appears in the quote below)_

## 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.

## 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/).