SMS Sp. z o.o.
PL-MF-000010604 · Poland · Góra Kalwaria
SMS Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 111 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 109 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: HMS08-0M, HMS04-GM, HMS08-GM, LUMO 6612 SDE, AS 669 WPA BLUE.
Among these devices, 111 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 | 111 |
| 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 |
|---|---|---|
1434-MDR-012/2024 | issued | 2030-01-29 |