Data / Medical devices / Italy / Centervue

Centervue: FDA-registered device maker in Padova Veneto, Italy, 7 510(k) clearances

Name: Centervue FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Centervue is registered with the FDA (registration 3008422902) in Padova Veneto, Italy. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 17, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008422902
Address: via San Marco 9h, Padova Veneto, Italy, 35129
Owner or operator: CenterVue (10032778)
Roles: Manufacturer, Specification developer
First device listed: September 24, 2015
Registered through: 2026
Brand names listed: COMPASS, DRSplus, EIDON, EIDON AF, EIDON FA, EIDON UWF Module, MAIA, RETIA 2 and more

Devices it lists

Device	Product code	Class	Role	Source
Ophthalmoscope, Laser, Scanning	MYC	2	Manufacturer, Specification developer	accessdata.fda.gov
Perimeter, Automatic, Ac-Powered	HPT	1	Manufacturer, Specification developer	accessdata.fda.gov
System, Image Management, Ophthalmic	NFJ	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
March 17, 2025	K243504	MAIA (AHMACME001)	MYC	Substantially Equivalent	Centervue S.P.A.	accessdata.fda.gov
August 22, 2024	K234076	iCare ALTIUS CW	NFJ	Substantially Equivalent	Centervue S.P.A.	accessdata.fda.gov
December 21, 2021	K213705	DRSplus	MYC	Substantially Equivalent	Centervue S.P.A.	accessdata.fda.gov
August 19, 2021	K211328	EIDON FA, EIDON, EIDON AF, EIDON UWFL	MYC	Substantially Equivalent	Centervue S.P.A.	accessdata.fda.gov
May 30, 2018	K180293	Retia 2	MYC	Substantially Equivalent	Centervue S.P.A.	accessdata.fda.gov
June 8, 2016	K153181	MAIA	MYC	Substantially Equivalent	Centervue S.P.A.	accessdata.fda.gov
June 30, 2015	K150320	COMPASS	MYC	Substantially Equivalent	Centervue S.P.A.	accessdata.fda.gov

Compare with other makers

Updated March 17, 2025. 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.