Calyx Medical Sp. z o.o.
PL-MF-000038787 · Poland · Wrocław
Calyx Medical Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|
Most frequent device types declared: URO 053, URO 054, SUR021, URO 058, SUR020.
Among these devices, 8 are declared sterile.
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 | Registered with FDA |
|---|---|
| Matched entry | CALYX MEDICAL Sp. Z.O.O. (PL) · FDA 3030450856 |
| Devices in EUDAMED | 8 |
| Country of registration | Poland |