Esaote S.p.A.
IT-MF-000019024 · Italy · Genova
Esaote S.p.A. is registered in the European database on medical devices as a manufacturer, with 310 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 309 |
|---|---|
| Class I | 1 |
Most frequent device types declared: 100009, 6200, 6250, 6440, 6450.
Among these devices, 309 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- CA1123
- CA431
- L 8-24
- LA523
- LUMBAR COIL N.18
- MyLab 9 Pro
- MyLab880
- MyLabX8 eHD
- SI2C41
- SL3116
- SL3235
- TCCX 3-14
Showing 12 of 310 declared devices.
Catalogue references include 100644022, 100645011, 100645014, 122000600, 130000006, 131000300.
European nomenclature codes declared: Z11040104, Z110402010101, Z110402010201, Z11040103, Z110402010301, Z1104020201.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ESAOTE S.P.A. (IT) · FDA 8043485 |
| Devices in EUDAMED | 310 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 310 |
|---|---|
| Found in the U.S. device database | 179 |
| Share | 57.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ESAOTE S.P.A |
What it holds in Canada
| Licences on record | 15 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 6 |
| Class 3 devices | 9 |
| First licensed | 1999-05-13 |
Licence types: Device Group Family (8), Device Family (3), System (3), Device Group (1).
Licensed under: ULTRASOUND IMAGING PROBES, MRI DEVICES, 6100/6200 ULTRASOUND SYSTEMS, 6150/6250 ULTRASOUND SYSTEMS, ULTRASOUND PROBE BIOPSY ATTACHMENTS, O-SCAN MRI SYSTEM.
North American profile: Both markets. Esaote S.p.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 095545 0032 | reissued | 2031-08-24 |
G10 095545 0024 | issued | 2026-08-24 |