FDA Device Establishments · JSON-LD · Markdown
FEI 3014165712 · Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3014165712 |
|---|---|
| Owner / Operator | PIKDARE S.P.A. (#10056365) |
| Address | Via Saldarini Catelli 10, Casnate con Bernate Como, 22070, IT |
| Mandatory US Agent | HTL-Strefa, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FMI |
| Regulation § (21 CFR) | 880.5570 |
| Proprietary names | ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES; Droplet 33G / Droplet 34G / Droplet 30G / Leader 33G; DROPLET PEN NEEDLE G34; INSUPEN PEN NEEDLE; DROPLET PEN NEEDLE G33; DROPLET PEN NEEDLE G30; LEADER PEN NEEDLE G33 |
Source: openFDA. Public-domain (CC0).