Abbott Ireland, Diagnostics Division
IE-MF-000009849 · Ireland · Sligo
Abbott Ireland, Diagnostics Division is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- ARCHITECT
Catalogue references include 01P3401, 01P3425, 01P3525, 02K4210, 02K4310.
European nomenclature codes declared: W0102152004, W0102080208, W05039080, W0102152201.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ABBOTT IRELAND DIAGNOSTICS DIVISION (IE) · FDA 3005094123 |
| Devices in EUDAMED | 5 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ABBOTT IRELAND, DIAGNOSTICS DIVISION |
What it holds in Canada
| Licences on record | 43 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 14 |
| Class 3 devices | 17 |
| Class 4 devices | 12 |
| First licensed | 2006-06-23 |
Licence types: Test Kit (36), System (7).
Licensed under: ARCHITECT I SYSTEM, ARCHITECT "I" SYSTEM, ARCHITECT SYSTEMS REAGENTS, ALINITY I SYSTEM SOLUTIONS, ALINITY I SYSTEM ASSAYS, ALINITY H SYSTEM REAGENTS AND SOLUTIONS.
North American profile: Both markets. Abbott Ireland, Diagnostics Division is registered in both the United States and Canada.