# Sandona Snc · 89-08 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

For Sandona Snc · 89-08 · ITALY, 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 ITALY; product is Sterling Silver Nipple Shield; product code is 80 H - - FS Shield, Nipple; date published is 02/01/2017; address is Via Carlo Alberto 50 , Treviso, Treviso ITALY, verified against its source on 2026-09-16.

- **Firm:** Sandona Snc _(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:** ITALY _(verified: appears in the quote below)_
- **Address:** Via Carlo Alberto 50 , Treviso, Treviso ITALY _(verified: appears in the quote below)_
- **Date published:** 02/01/2017 _(verified: appears in the quote below)_
- **Product code:** 80 H - - FS Shield, Nipple _(verified: appears in the quote below)_
- **Product:** Sterling Silver Nipple Shield _(verified: appears in the quote below)_
- **FDA notes:** Class I device without a valid 510k _(verified: appears in the quote below)_

## What the source says

> Sandona Snc Date Published : 02/01/2017 Via Carlo Alberto 50 , Treviso, Treviso ITALY 80 H - - FS Shield, Nipple Date Published: 02/01/2017 Desc: Sterling Silver Nipple Shield Notes: Class I device without a valid 510k

## 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/).