INORIS MEDICAL SP. Z O.O.
PL-MF-000016864 · Poland · KOWARY
INORIS MEDICAL SP. Z O.O. is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 13 |
|---|
Most frequent device types declared: IM-40, im-20, IM-1070 TUBEGUARD, IM-50, IM-60.
Among these devices, 1 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 | INORIS MEDICAL SP. Z O.O. (PL) · FDA 3010806663 |
| Devices in EUDAMED | 13 |
| Country of registration | Poland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1434-MDR-007/2026 | issued | 2031-04-02 |