Innate s.r.l.
IT-MF-000026730 · Italy · Novi Ligure
Innate s.r.l. is registered in the European database on medical devices as a manufacturer, with 48 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 48 |
|---|
Most frequent device types declared: 1 mL syringe based on cross-linked sodium hyaluronate, 2 mL syringe based on 1,2% sodium hyaluronate medium molecular weight , 2 mL syringe based on high molecular weight hyaluronic acid, 2 mL syringe based on high molecular weight hyaluronic acid and niacin, 2 mL syringe based on medium molecular weight hyaluronic acid.
Among these devices, 48 are declared sterile, 48 implantable.
Devices declared under this manufacturer
- Dives Med Trehfill
- Haequeo Supreme
- Innea
- Innea Aqua
- Optilace Model Preciso
- Playal 40
- Promovia 60
- Promovia Hydro Balance 100
- Promovia Hydro Balance 50
- Resteeme L
- Resteeme X
- Viscoial 24
Showing 12 of 48 declared devices.
Catalogue references include DIV02V, INN03, INN104, INN110, INN30, ROS06V.
European nomenclature codes declared: P900402.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 48 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 48 |
|---|---|
| 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. Innate s.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
EPT 0477.MDR.25/5697 | issued | 2027-07-31 |
EPT 0477.MDR.25/5696 | issued | 2027-07-31 |
EPT 0477.MDR.24/5690.1 | reissued | 2027-07-31 |
EPT 0477.MDR.24/5689.1 | reissued | 2027-07-31 |
EPT 0477.MDR.22/4901.4 | reissued | 2027-07-31 |
064-00-01-MDR | issued | 2029-11-13 |
063-00-00-MDR | issued | 2029-11-13 |