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CENTERVUE S.P.A.

Italy·IT-MF-000017082

Last updated September 18, 2026

About

iCare provides eye doctors with the latest solutions for comprehensive screening, diagnostics and monitoring of glaucoma, diabetic retinopathy, and macular degeneration (AMD). Our product line includes automated TrueColor imaging devices, perimeters and handheld rebound tonometers.

From the manufacturer's own website. Source

What CENTERVUE S.P.A. makes

CenterVue S.p.A. manufactures digital retinal imaging systems, including devices for wide-field fundus photography and macular integrity assessment, such as the CenterVue Digital Retinography System and Macular Integrity Assessment. Their portfolio also includes handheld rebound tonometers (e.g., iCare Altius CW, iCare Maia, S-Maia) for intraocular pressure measurement, as well as handheld retinal cameras (e.g., Eidon FA, Eidon UWF Module) for non-mydriatic imaging. Additional products include portable diagnostic tools like the iCare RetCAD for automated retinal imaging and the MAIA Model 1 for glaucoma screening.

The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, and Class IIa, with listings in the EU’s eudamed registry and FDA’s 510(k) clearance database. These products are designed for ophthalmic diagnostics, including glaucoma, diabetic retinopathy, and age-related macular degeneration. The manufacturer is based in Italy.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
Italy
Address
9/H, Via San Marco, Padova, Italy
Facebook
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Phone
+39 049 501 8399
PRRC Contact
Luca Scienza
EUDAMED SRN
IT-MF-000017082
FDA FEI Number
—
DUNS Number
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Catalogue (17)

DeviceModel / ReferenceRegistriesClassStatus
Centervue Digital Retinography System K101935
FDA 510(k)
Class IIActive
Centervue Macular Integrity Assessment K133758
FDA 510(k)
Class IIActive
Eidon Fa, Eidon, Eidon Af, Eidon Uwfl K211328
FDA 510(k)
Class IIActive
iCare ALTIUS CW K234076
FDA 510(k)
Class IIActive
Maia, Model 1 K092187
FDA 510(k)
Class IActive
iCare MAIA AHMACME001
EUDAMED
Class IIaActive
S-Maia ACMASME002
EUDAMEDFDA UDI
Class IIaActive
iCare RETCAD RRTCPRM000
EUDAMED
Class IIaActive
Eidon Fa AIFLAME001
EUDAMEDFDA UDI
Class IIaActive
EIDON UWF Module AXWFLME001
EUDAMED
Class IActive
Eidon AMFUNME001
EUDAMEDFDA UDI
Class IIaActive
Eidon Af AIFLUME001
EUDAMEDFDA UDI
Class IIaActive
Compass AMGSDME001
EUDAMEDFDA UDI
Class IIaActive
Retia2 AINEUME002
EUDAMEDFDA UDI
Class IIaActive
Drs ADDRSME002
EUDAMEDFDA UDI
Class IIaActive
Maia ATMARME002
EUDAMEDFDA UDI
Class IIaActive
DRSplus AXSDRME100
EUDAMEDFDA UDI
Class IIaActive

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