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

For Orkla Care 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 is Cederroth Breathing Mask; product code is 73 C - - BP Valve, Non-Rebreathing; date published is 05/19/2011; address is Svetsarvagen 15 , Solna, Stockholms Lan SWEDEN, verified against its source on 2026-09-16.

- **Firm:** Orkla Care 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:** Svetsarvagen 15 , Solna, Stockholms Lan SWEDEN _(verified: appears in the quote below)_
- **Date published:** 05/19/2011 _(verified: appears in the quote below)_
- **Product code:** 73 C - - BP Valve, Non-Rebreathing _(verified: appears in the quote below)_
- **Product:** Cederroth Breathing Mask _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Orkla Care AB Date Published : 05/19/2011 Svetsarvagen 15 , Solna, Stockholms Lan SWEDEN 73 C - - BP Valve, Non-Rebreathing Date Published: 05/19/2011 Desc: Cederroth Breathing Mask Notes: Class II

## 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/).