# Lebian International S R L · 89-08 · ARGENTINA — FDA import alert red lists: firms subject to detention without physical examination

For Lebian International S R L · 89-08 · ARGENTINA, 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 ARGENTINA; product is Gynecological devices (Small #2; Medium #3; Large #4); product code is 85 H - - -- Portion of device code; date published is 05/16/2014; address is Calle La Paz 1071 , Rosario, Santa Fe ARGENTINA, verified against its source on 2026-09-16.

- **Firm:** Lebian International S R L _(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:** ARGENTINA _(verified: appears in the quote below)_
- **Address:** Calle La Paz 1071 , Rosario, Santa Fe ARGENTINA _(verified: appears in the quote below)_
- **Date published:** 05/16/2014 _(verified: appears in the quote below)_
- **Product code:** 85 H - - -- Portion of device code _(verified: appears in the quote below)_
- **Product:** Gynecological devices (Small #2; Medium #3; Large #4) _(verified: appears in the quote below)_
- **FDA notes:** Autoexpandable and Discardable Speculum for Gynecological Use Models _(verified: appears in the quote below)_

## What the source says

> Lebian International S R L Date Published : 05/16/2014 Calle La Paz 1071 , Rosario, Santa Fe ARGENTINA 85 H - - -- Portion of device code Date Published: 05/16/2014 Desc: Gynecological devices (Small #2; Medium #3; Large #4) Notes: Autoexpandable and Discardable Speculum for Gynecological Use Models

## 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/).