Data / Medical devices / Italy / Eurospital S.P.A.
Eurospital S.P.A.: FDA-registered device maker in Trieste, Italy, 7 510(k) clearances
Eurospital S.P.A. is registered with the FDA (registration 9615139) in Trieste, Italy. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 10, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615139
- FEI number
- 1000553563
- Address
- Via Flavia 122, Trieste, Italy, 34147
- Owner or operator
- EUROSPITAL S.P.A. (9039568)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 3, 2010
- Registered through
- 2026
- Brand names listed
- Calprest, Calprest®NG, EasyCal, Eu-tTG IgA, Eu-tTG IgG, Fecal Extraction Device, PhiCal Test, QUANTA Lite Calprotectin Extended Range
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antibodies, Gliadin | MST | 2 | Manufacturer | accessdata.fda.gov |
| Autoantibodies, Endomysial(Tissue Transglutaminase) | MVM | 2 | Manufacturer | accessdata.fda.gov |
| Calprotectin, Fecal | NXO | 2 | Contract manufacturer, 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 10, 2019 | K191592 | CalprestNG, EasyCal | NXO | Substantially Equivalent | Eurospital S.P.A. | accessdata.fda.gov |
| July 10, 2019 | K191589 | Calprest, EasyCal | NXO | Substantially Equivalent | Eurospital S.P.A. | accessdata.fda.gov |
| November 10, 2016 | K160447 | Calprest NG | NXO | Substantially Equivalent | Eurospital S.P.A. | accessdata.fda.gov |
| January 16, 2014 | K130945 | CALPREST | NXO | Substantially Equivalent | Eurospital S.P.A. | accessdata.fda.gov |
| December 14, 2012 | K113377 | GLIADIN IGA AND GLIADIN LGA | MST | Substantially Equivalent | Grifols USA, LLC | accessdata.fda.gov |
| March 7, 2011 | K102964 | EU-TTG IGA AND EU-TTG IGG | MVM | Substantially Equivalent | Grifols USA, Inc. | accessdata.fda.gov |
| April 26, 2006 | DEN060001 | PHICAL TEST | NXO | Unknown | Genova Diagnostics | accessdata.fda.gov |
Compare with other makers
- All makers of Calprotectin, Fecal
- All makers of Antibodies, Gliadin
- All makers of Autoantibodies, Endomysial(Tissue Transglutaminase)
Updated July 10, 2019. 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.