Pikdare S.p.A.
IT-MF-000010069 · Italy · Casnate con Bernate
Pikdare S.p.A. is registered in the European database on medical devices as a manufacturer, with 691 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 675 |
|---|---|
| Class IIb | 16 |
Most frequent device types declared: PEN NEEDLE, Syringe with needle, Self-protected Insulin syringe, Eccentric Luer syringe with needle, Luer Lock syringe.
Among these devices, 429 are declared sterile, 39 active, 23 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PIKDARE S.p.A. (IT) · FDA 3014165712 |
| Devices in EUDAMED | 691 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1984728 1 | supplemented | 2027-05-02 |
ITH 1984728 1 | issued | 2027-05-02 |