WISE S.p.A.
IT-MF-000012628 · Italy · Cologno Monzese
WISE S.p.A. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 2 |
|---|---|
| Class I | 3 |
Among these devices, 4 are declared sterile.
Devices declared under this manufacturer
- WCS®
- WCS® Link
- WISE Cortical Strip
- WISE Cortical Strip - WCS
Catalogue references include WCS00-4S10-000, WCS04S10A-00-002, WCS04S10A-00-003, WSCC_4CH, WSCC_4CH-001.
European nomenclature codes declared: N0101020101, Z12100380.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | WISE S.p.A. (IT) · FDA 3030387292 |
| Devices in EUDAMED | 5 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 4 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 25.0 % |
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: United States only. WISE S.p.A. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
70944 | issued | 2031-04-20 |
1434-MDR-006/2025 | issued | 2030-06-17 |
1434-MDR-005/2025 | amended | 2030-06-17 |