Cardio Surgical Ltd.
IE-MF-000011150 · Ireland · Galway
Cardio Surgical Ltd. is registered in the European database on medical devices as a manufacturer, with 906 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 906 |
|---|
Most frequent device types declared: CS3-1005-18\t, CS5-1007-09, CS5-1014-09, CS5-2001-14, CS5-2205-35\t.
Among these devices, 8 are declared sterile, 904 reusable, 2 with a measuring function.
Catalogue references include CS3-1005-18\t, CS5-1007-09, CS5-2001-14, CS5-2205-35\t, CS9-2016-14\t, FST-1660-21\t.
European nomenclature codes declared: L080599, L03130401, L0205, L01040402, L03140199, L010413.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 906 |
| Country of registration | Ireland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 906 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Cardio Surgical Ltd. was not found in either the U.S. or the Canadian register.