Diaco Biofarmaceutici srl
IT-MF-000012117 · Italy · Trieste
Diaco Biofarmaceutici srl is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 34 |
|---|---|
| Class IIa | 1 |
Most frequent device types declared: EasyGo, EasyGo One, Sterile solution for intravescical administration 0.16% 50 ml.
Among these devices, 35 are declared sterile, 34 implantable.
Devices declared under this manufacturer
- Diart 1,1% 1 ml
- Diart 1,1% 2 ml
- Diart 1,8% 1 ml
- Diart 1,8% 2 ml
- Diart One 40 mg 2 ml
- Diart One 60 mg 2 ml
- Diart One 80 mg 4 ml
- Diart One 90 mg 3 ml
- EasyGo 1.8% 2 ml
- EasyGo One 90 mg 3 ml
- Instylan 0.16%
Showing 12 of 35 declared devices.
Catalogue references include 6011, 6091, 6093, 6100, 6101, 6104.
European nomenclature codes declared: P900402, U1301.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 35 |
| 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 | 34 |
|---|---|
| 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. Diaco Biofarmaceutici srl was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CVD005326 | issued | 2031-02-11 |
CVD005226 | issued | 2031-02-11 |
CSQ0033260126 | supplemented | 2031-02-11 |