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-01, IM-1070 TUBEGUARD, IM-40, IM-45, IM-50.
Among these devices, 1 are declared sterile.
Devices declared under this manufacturer
- CLIP-ON BITEGUARD
- GASTROGUARD
- IM-1080 TUBEGUARD
- REUSABLE GASTROGUARD
Showing 12 of 13 declared devices.
Catalogue references include IM 1070 TUBEGUARD, IM 65, IM-02, IM-10, IM-1060, IM-1090 TUBEGUARD.
European nomenclature codes declared: G030804, R01038099, G030804,R01038099.
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 |
Device-level evidence
| Devices with a numeric GTIN | 13 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 23.1 % |
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: United States only. INORIS MEDICAL SP. Z O.O. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1434-MDR-007/2026 | issued | 2031-04-02 |