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: Amber syringe for Pumps, COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE, Eccentric Luer syringe with needle, Hypertonic saline solution, Insulin syringe.
Among these devices, 429 are declared sterile, 39 active, 23 with a measuring function.
Devices declared under this manufacturer
- Benda a rete
- ECCENTRIC LUER SYRINGES WITH NEEDLE
- Flexa Soft
- INSULIN SYRINGES
- Insupen ADVANCED
- Insupen EVOLVE
- Insupen Original
- SELF-PROTECTED INSULIN SYRINGES
- SYRINGES WITH NEEDLE
- Siringa con Ago
- Siringa senza Ago
- Soffix Med
Showing 12 of 691 declared devices.
Catalogue references include 02002264090050, 58000011000080, 58004476000000, 58022672200000, 58022925500000, 81000100203000.
European nomenclature codes declared: A0101010202, A020199, M050101, M030402010101, M03040299, M04010101.
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 |
Device-level evidence
| Devices with a numeric GTIN | 691 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PIKDARE S.P.A. |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2018-08-23 |
Licence types: Device Family (3).
Licensed under: INSUMED - SYRINGES FOR INSULIN, INSUPEN - PEN NEEDLE, DROPSAFE SICURA PROTECTO SMARTSAFE PASSIVE SAF.
North American profile: Both markets. Pikdare S.p.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1984728 1 | supplemented | 2027-05-02 |
ITH 1984728 1 | issued | 2027-05-02 |