TatraMed Software s.r.o.
SK-MF-000017681 · Slovakia · Bratislava
TatraMed Software s.r.o. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: TomoCon GO - versions 1.0, 2.0, 2.1, 2.2, 2.3, 2.4, TomoCon PACS - versions: 25; 24; 23; 22; 21; 20; 19; 18..
Among these devices, 6 are declared active, 5 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 | 6 |
| Country of registration | Slovakia |
⚠️ 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2024-MDR/QS-010 | issued | 2029-03-06 |