SkandiaLife Manufacturing · 89-08 · ESTONIA
For SkandiaLife Manufacturing, import alert is 89-08; country is ESTONIA; 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 Sybaritic Inc. (Sybaritic) Hydration Station; product code is 89 I - - MB Cabinet, Moist Steam; date published is 09/29/2009; address is Varbola Kula, Marjamaa Vald , Raplamaa, ESTONIA, verified against its source on 2026-09-30.
- Firm
- SkandiaLife Manufacturing 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
- ESTONIA verified
- Address
- Varbola Kula, Marjamaa Vald , Raplamaa, ESTONIA verified
- Date published
- 09/29/2009 verified
- Product code
- 89 I - - MB Cabinet, Moist Steam verified
- Product
- Sybaritic Inc. (Sybaritic) Hydration Station verified
- FDA notes
- Class II; 9/1/2009 verified
What the source says
SkandiaLife Manufacturing Date Published : 09/29/2009 Varbola Kula, Marjamaa Vald , Raplamaa, ESTONIA
— 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
89 I - - MB Cabinet, Moist Steam Date Published: 01/30/2019 Desc: Sybaritic Inc. (Sybaritic) Hydration Station Notes: Class II; 9/1/2009
— 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.