RESTECH SRL
IT-MF-000026505 · Italy · MILANO
RESTECH SRL 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 | 5 |
|---|
Most frequent device types declared: Resmon PRO DIARY, Resmon PRO FULL, Resolve.
Among these devices, 4 are declared active, 4 with a measuring function.
Devices declared under this manufacturer
- FIRST
- FIRST.HOME
- Resmon PRO DIARY
- Resmon PRO FULL
- Resolve
Catalogue references include RT1100, RT1101, RT1103, RT1104, RT1105.
European nomenclature codes declared: Z12159099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | RESTECH SRL (IT) · FDA 3012624216 |
| Devices in EUDAMED | 5 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 20.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | RESTECH SRL |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2017-04-12 |
Licence types: Single Device (1), System (1).
Licensed under: RESMON PRO FULL, FIRST.
North American profile: Both markets. RESTECH SRL is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
139/MDR | supplemented | 2028-11-19 |