Hemcon Medical Technologies Europe, Ltd. · 89-08 · IRELAND
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
- 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
- Address
- Blackrocks , 515 Orwell Park Way , Dublin 6w, Co. DUBLIN IRELAND verified
- Date published
- 09/08/2015 verified
- Product code
- 77 L - - YA Splint, Intranasal Septal verified
- Product
- Splint; Intranasal Septal verified
- FDA notes
- Class I; Synaero verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.