# SkandiaLife Manufacturing · 89-08 · ESTONIA — FDA import alert red lists: firms subject to detention without physical examination

For SkandiaLife Manufacturing · 89-08 · ESTONIA, 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 ESTONIA; 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 2026-09-16.

- **Firm:** SkandiaLife Manufacturing _(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:** ESTONIA _(verified: appears in the quote below)_
- **Address:** Varbola Kula, Marjamaa Vald , Raplamaa, ESTONIA _(verified: appears in the quote below)_
- **Date published:** 09/29/2009 _(verified: appears in the quote below)_
- **Product code:** 89 I - - MB Cabinet, Moist Steam _(verified: appears in the quote below)_
- **Product:** Sybaritic Inc. (Sybaritic) Hydration Station _(verified: appears in the quote below)_
- **FDA notes:** Class II; 9/1/2009 _(verified: appears in the quote below)_

## What the source says

> SkandiaLife Manufacturing Date Published : 09/29/2009 Varbola Kula, Marjamaa Vald , Raplamaa, ESTONIA 89 I - - MB Cabinet, Moist Steam Date Published: 01/30/2019 Desc: Sybaritic Inc. (Sybaritic) Hydration Station Notes: Class II; 9/1/2009

## 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/).