Data / Medical devices / Italy / Pentaferte Italia S.R.L.
Pentaferte Italia S.R.L.: FDA-registered device maker in CAMPLI Teramo, Italy, 4 510(k) clearances
Pentaferte Italia S.R.L. is registered with the FDA (registration 3004756837) in CAMPLI Teramo, Italy. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 20, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004756837
- Address
- Viale Piane Nocella, 23, CAMPLI Teramo, Italy, 64012
- Owner or operator
- PENTAFERTE ITALIA s.r.l. (10057694)
- Roles
- Manufacturer
- First device listed
- May 15, 2018
- Registered through
- 2026
- Brand names listed
- CRN CRONO SYRINGE RESERVOIR, NUTRIFIT, Nutrifit, Pentaflush
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Manufacturer | accessdata.fda.gov |
| Saline, Vascular Access Flush | NGT | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | 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 |
|---|---|---|---|---|---|---|
| July 20, 2022 | K214080 | Pentaflush | NGT | Substantially Equivalent | Pentaferte Italia S.R.L. | accessdata.fda.gov |
| February 28, 2022 | K211661 | ENFit enteral syringes (NUTRIFIT) | PNR | Substantially Equivalent | Pentaferte Italia S.R.L. | accessdata.fda.gov |
| March 22, 2017 | K161141 | ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT | PNR | Substantially Equivalent | Pentaferte Italia S.R.L. | accessdata.fda.gov |
| January 11, 2001 | K002381 | PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES | FMF | Substantially Equivalent | Pentaferte, S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Saline, Vascular Access Flush
- All makers of Enteral Syringes With Enteral Specific Connectors
Updated July 20, 2022. 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.