Comarch Telemedicine Sp. z o.o.
PL-MF-000049884 · Poland · Kraków
Comarch Telemedicine Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 34 |
|---|
Most frequent device types declared: Comarch e-Care 2.0, ECG.Viewer.P2, Comarch HomeHealth 2.0, CARDIOVIEWER.P2, Comarch Sleep Polygraph Viewer.
Among these devices, 34 are declared active.
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 | 34 |
| Country of registration | Poland |
⚠️ 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 |
|---|---|---|
HZ 2705175-1 | issued | 2027-07-17 |