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: AS 6618 WPA, AS 669 WPA BLUE, DGM AND-600-1, HMS04-GM, HMS04-GP.
Among these devices, 111 are declared active.
Devices declared under this manufacturer
- AS 6618 WPA
- AS 669 A BLUE
- AS 669 WPA BLUE
- DGM AND-600-1
- HMS04-GM
- HMS04-GP
- HMS08-0M
- HMS08-GM
- HMS12-0P
- LUMO 446 DDE
- LUMO 6612 SDE
- LUMO 6615 DDE
Showing 12 of 111 declared devices.
Catalogue references include 0973-211-074, 0973-213-187, 0973-213-196, 0973-213-206, 0973-213-212, 0973-213-214.
European nomenclature codes declared: Z12011304, Z12011309, Z12011301.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 111 |
| 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 | 111 |
|---|---|
| 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. SMS Sp. z o.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1434-MDR-012/2024 | issued | 2030-01-29 |