Data / Medical devices / Italy / Pierrel S.P.A.
Pierrel S.P.A.: FDA-registered device maker in Capua Caserta, Italy, 1 510(k) clearance
Pierrel S.P.A. is registered with the FDA (registration 3006999064) in Capua Caserta, Italy. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 15, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006999064
- Address
- Strada Statale Appia 7 bis 46/48, Capua Caserta, Italy, 81043
- Owner or operator
- PIERREL S.P.A. (10050470)
- Roles
- Foreign private label distributor, Repackager or relabeler, Specification developer
- First device listed
- November 20, 2015
- Registered through
- 2027
- Brand names listed
- G.o.c.c.l.e.s., G.o.c.c.l.e.s. light, Orabloc - needle stick safety system, Orabloc thirtyES, Orabloc thirtyS, Orabloc twenty5L, Orabloc twenty7L, Orabloc twenty7S and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diagnostic Light, Soft Tissue Detector | NXV | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Foreign private label distributor | 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 |
|---|---|---|---|---|---|---|
| September 15, 2015 | K151630 | G.o.c.c.l.e.s. | NXV | Substantially Equivalent | Pierrel Pharma S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Diagnostic Light, Soft Tissue Detector
- All makers of Needle, Dental
Updated September 15, 2015. 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.