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: CS5-2205-35\t, SSD-508-16\t, CS9-2016-14\t, SCG-936-18T\t, FST-1660-21\t.
Among these devices, 8 are declared sterile, 904 reusable, 2 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 906 |
| Country of registration | Ireland |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.