Orkla Care AB · 89-08 · SWEDEN
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
- 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
- Svetsarvagen 15 , Solna, Stockholms Lan SWEDEN verified
- Date published
- 05/19/2011 verified
- Product code
- 73 C - - BP Valve, Non-Rebreathing verified
- Product
- Cederroth Breathing Mask verified
- FDA notes
- Class II verified
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
— 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.