Eurospital S.P.A.
ItalyFDA 510(k) applicant, unverified FDA FEI 1000553563
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Eurospital S.P.A. makes
Eurospital S.P.A. manufactures calibration systems for medical imaging devices, including the CalprestNG and EasyCal platforms. These tools are designed to automate and streamline the calibration process for diagnostic imaging equipment, ensuring accuracy and compliance with quality standards.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The portfolio is regulated in the United States, where Eurospital S.P.A. is based.
Catalogue
CalprestNG, EasyCal Ref K191592
510(k) 510(k)Calprest, EasyCal Ref K191589
510(k) 510(k)
Company details
- FDA FEI number
- 1000553563
- Address
- VIA FLAVIA 122, TRIESTE
Frequently asked questions
How many devices does Eurospital S.P.A. have in the registry?
The registry currently lists 2 devices for Eurospital S.P.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eurospital S.P.A.'s devices?
Among its 2 most recently registered devices, Eurospital S.P.A. has devices listed in FDA 510(k) (2 devices).
What risk classes do Eurospital S.P.A.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Eurospital S.P.A.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Eurospital S.P.A. in the registry?
The most recently registered devices listed for Eurospital S.P.A. include CalprestNG, EasyCal and Calprest, EasyCal.