# Hemcon Medical Technologies Europe, Ltd. · 89-08 · IRELAND — FDA import alert red lists: firms subject to detention without physical examination

For Hemcon Medical Technologies Europe, Ltd. · 89-08 · IRELAND, 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 IRELAND; product is Splint; Intranasal Septal; product code is 77 L - - YA Splint, Intranasal Septal; date published is 09/08/2015; address is Blackrocks , 515 Orwell Park Way , Dublin 6w, Co. DUBLIN IRELAND, verified against its source on 2026-09-16.

- **Firm:** Hemcon Medical Technologies Europe, Ltd. _(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:** IRELAND _(verified: appears in the quote below)_
- **Address:** Blackrocks , 515 Orwell Park Way , Dublin 6w, Co. DUBLIN IRELAND _(verified: appears in the quote below)_
- **Date published:** 09/08/2015 _(verified: appears in the quote below)_
- **Product code:** 77 L - - YA Splint, Intranasal Septal _(verified: appears in the quote below)_
- **Product:** Splint; Intranasal Septal _(verified: appears in the quote below)_
- **FDA notes:** Class I; Synaero _(verified: appears in the quote below)_

## What the source says

> Hemcon Medical Technologies Europe, Ltd. Date Published : 09/08/2015 Blackrocks , 515 Orwell Park Way , Dublin 6w, Co. DUBLIN IRELAND 77 L - - YA Splint, Intranasal Septal Date Published: 09/08/2015 Desc: Splint; Intranasal Septal Notes: Class I; Synaero

## 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/).