Echo-Son SA
PL-MF-000004830 · Poland · Puławy
Echo-Son SA is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 20 |
|---|
Most frequent device types declared: ALBIT, CA 255, LA 510, OA 12, OB 12.
Among these devices, 20 are declared active, 6 with a measuring function.
Devices declared under this manufacturer
- ALBIT
- CA 255
- LA 510
- OB 12
- OP 20
- PINIT
- R 510
- S 255B
- Skaner biometryczny PIROP
- Sonda OA 12
- Sonda OP 20
- Sonda S 255B
Showing 12 of 20 declared devices.
Catalogue references include 5904292005000, 5904292005031, 5904292005048, 5904292005079, 5904292005116, 5904292005161.
European nomenclature codes declared: Z11040299, Z110402010201, Z110402010101, Z12080304, Z11040199, Z12120102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 20 |
| 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 | 20 |
|---|---|
| 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. Echo-Son SA was not found in either the U.S. or the Canadian register.