AOTI Limited
IE-MF-000025075 · Ireland · Galway
AOTI Limited is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 22 |
|---|
Most frequent device types declared: Hyper-Box System.
Among these devices, 22 are declared active.
Devices declared under this manufacturer
- Hyper-Box System, Austria
- Hyper-Box System, Belgium
- Hyper-Box System, Cyprus
- Hyper-Box System, Finland
- Hyper-Box System, Germany
- Hyper-Box System, Greece
- Hyper-Box System, Italy
- Hyper-Box System, Netherlands
- Hyper-Box System, Portugal
- Hyper-Box System, Slovenia
- Hyper-Box System, Spain
- Hyper-Box System, Sweden
Showing 12 of 22 declared devices.
Catalogue references include G00001-2-CHE, G00001-2-CYP, G00001-2-DEU, G00001-2-GRC, G00001-2-PRT, G00001-2-SVN.
European nomenclature codes declared: A99.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AOTI LTD. (IE) · FDA 3006538358 |
| Devices in EUDAMED | 22 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 22 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AOTI LTD. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2011-03-22 |
Licence types: System (1).
Licensed under: AOTI HYPER-BOX SYSTEM.
North American profile: Both markets. AOTI Limited is registered in both the United States and Canada.