Orkla Care AB · 89-08 · SWEDEN
For Orkla Care 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 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 2026-09-30.
- 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
— 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, Product and FDA notes
73 C - - BP Valve, Non-Rebreathing Date Published: 05/19/2011 Desc: Cederroth Breathing Mask Notes: Class II
— 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.