Data / Medical devices / Italy / PIKDARE S.p.A.
PIKDARE S.p.A.: FDA-registered device maker in Casnate con Bernate Como, Italy, 5 510(k) clearances
PIKDARE S.p.A. is registered with the FDA (registration 3014165712) in Casnate con Bernate Como, Italy. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014165712
- Address
- Via Saldarini Catelli 10, Casnate con Bernate Como, Italy, 22070
- Owner or operator
- PIKDARE S.P.A. (10056365)
- Roles
- Complaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer
- First device listed
- December 1, 2017
- Registered through
- 2026
- Brand names listed
- ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES, ARTSANA PISTON AND INSULIN SYRINGES, DROPLET PEN NEEDLE G30, DROPLET PEN NEEDLE G33, DROPLET PEN NEEDLE G34, DropSafe Sicura, Droplet 33G / Droplet 34G / Droplet 30G / Leader 33G, INSUPEN ADVANCED Pen Needles and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 20, 2023 | K203792 | Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle | FMI | Substantially Equivalent | Pikdare Spa | accessdata.fda.gov |
| December 2, 2022 | K223353 | DropSafeTM SicuraTM | FMI | Substantially Equivalent | Pikdare Spa | accessdata.fda.gov |
| February 10, 2016 | K151311 | Safe Block Pen Needle | FMI | Substantially Equivalent | Artsana S.P.A | accessdata.fda.gov |
| November 25, 2005 | K052667 | ARTSANA PISTON AND INSULIN SYRINGES | FMF | Substantially Equivalent | Artsana S.P.A | accessdata.fda.gov |
| October 4, 2005 | K051783 | ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES | FMI | Substantially Equivalent | Artsana S.P.A | accessdata.fda.gov |
Compare with other makers
Updated January 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.