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: CARDIOVIEWER.P2, CMAP.P1, Comarch Holter, Comarch HomeHealth 2.0, Comarch Sleep Polygraph Viewer.
Among these devices, 34 are declared active.
Devices declared under this manufacturer
- Comarch CardioViewer
- Comarch ECGViewer 2.0
- Comarch Holter
- Comarch HomeHealth 2.0
- Comarch Medical Analysis Platform (CMAP)
- Comarch Sleep Polygraph Viewer
- Comarch e-Care 2.0
Showing 12 of 34 declared devices.
Catalogue references include 05905331580007, 05905331580021, 05905331580076, 05905331580120, 05905331580243, 05905331580281.
European nomenclature codes declared: Z1203020692, Z12050492.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 34 |
| Country of registration | Poland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 34 |
|---|---|
| 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. Comarch Telemedicine Sp. z o.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 2705175-1 | issued | 2027-07-17 |