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.
Devices declared under this manufacturer
- RTmedes 1.6
- TomoCon GO - versions 1.0, 2.0, 2.1, 2.2, 2.3, 2.4
- TomoCon GO 3.0
- TomoCon GO 4.0
- TomoCon GO 5.0
- TomoCon PACS
Catalogue references include RTmedes - Build: 1.6.21168.1, TomoCon GO, TomoCon GO 3.0, TomoCon GO 4.0, TomoCon GO 5.0, TomoCon PACS & Diagnostic stations.
European nomenclature codes declared: Z11069005, Z119092, Z11030592,Z110603,Z11069005.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| Country of registration | Slovakia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 4 |
|---|---|
| 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. TatraMed Software s.r.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2024-MDR/QS-010 | issued | 2029-03-06 |