# Aegis Lifesciences · 89-08 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For Aegis Lifesciences · 89-08 · INDIA, 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 INDIA; product is Agent Aborbable Hemostatic Collagen Blend; product code is 79 L - - MF Agent, Absorbable Hemostatic, Collagen Based; date published is 03/10/2014; address is 215/216 Mahagujrat Industrial , Moraiy , Changodar, Gujarat INDIA, verified against its source on 2026-09-16.

- **Firm:** Aegis Lifesciences _(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:** INDIA _(verified: appears in the quote below)_
- **Address:** 215/216 Mahagujrat Industrial , Moraiy , Changodar, Gujarat INDIA _(verified: appears in the quote below)_
- **Date published:** 03/10/2014 _(verified: appears in the quote below)_
- **Product code:** 79 L - - MF Agent, Absorbable Hemostatic, Collagen Based _(verified: appears in the quote below)_
- **Product:** Agent Aborbable Hemostatic Collagen Blend _(verified: appears in the quote below)_
- **FDA notes:** Class III _(verified: appears in the quote below)_

## What the source says

> Aegis Lifesciences Date Published : 03/10/2014 215/216 Mahagujrat Industrial , Moraiy , Changodar, Gujarat INDIA 79 L - - MF Agent, Absorbable Hemostatic, Collagen Based Date Published: 03/10/2014 Desc: Agent Aborbable Hemostatic Collagen Blend Notes: Class III

## 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/).