Manufacturer of medical devices registered in the European database in Cologno Monzese, Italy.
| Registration number (SRN) | IT-MF-000012628 |
|---|---|
| Short name | WISE |
| Role | Manufacturer |
| Status | Active |
| Country | Italy |
| City | 20093 Cologno Monzese |
| Address | Michelangelo Buonarroti, 38 20093 Cologno Monzese |
| Registered on | 2021-09-01 |
| FDA establishment register | Registered with the U.S. FDA |
|---|---|
| Matched entry | WISE S.p.A. (IT) · FDA 3030387292 |
| Certificate | Status | Expiry | Type | Body |
|---|---|---|---|---|
70944 | valid | 2031-04-20 | Quality management system | NB 0546 |
1434-MDR-006/2025 | valid | 2030-06-17 | Quality management system | NB 1434 |
1434-MDR-005/2025 | amended | 2030-06-17 | Technical documentation | NB 1434 |
⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.
The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.
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