CENTERVUE SPA

Address:via San Marco 9h,Padova Veneto,IT

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Ophthalmoscope, Laser, Scanning (MYC) (3) Ophthalmoscope,Laser,Scanning (MYC) (3) Perimeter, Automatic, Ac-Powered (HPT) (3) Camera, Ophthalmic, Ac-Powered (HKI) (2)

Premarket Exempt

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DRS - 08053677040017 Catalog Number :

Device Description : FUNDUS CAMERA

Device Class : 2

Duns Number: 338702316

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

MAIA - 08053677040024 Catalog Number : ATMARME002

Device Description : MAIA is intended for measuring macular sensitivity, fixation stability and the l MAIA is intended for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

Device Class : 1

Duns Number: 338702316

Premarket Exempt : No

Product Code : HPT

Prescription Use : Yes

Device Count : 1

EIDON - 08053677040031 Catalog Number : AMFUNME01

Device Description : EIDON is a scanning ophthalmoscope which uses infrared and visible light to obta EIDON is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal images of the retina, without pharmacological dilation. EIDON is a standalone device.

Device Class : 2

Duns Number: 338702316

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

COMPASS - 08053677040048 Catalog Number : AMGSDME01

Device Description : COMPASS is a scanning ophthalmoscope combined with an automatic perimeter that a COMPASS is a scanning ophthalmoscope combined with an automatic perimeter that allows the acquisition of images of the retina, as well as the measurement of retinal threshold sensitivity and the analysis of fixation..

Device Class : 1

Duns Number: 338702316

Premarket Exempt : No

Product Code : HPT

Prescription Use : Yes

Device Count : 1

MAIA - 08053677040055 Catalog Number : ACMASME002

Device Description : S-MAIA is intended for measuring macular sensitivity, fixation stability and the S-MAIA is intended for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects. The S-MAIA allows also the measurement of macular sensitivity and fixation under scotopic (or low light) background conditions, in addition to the standard measurement performed in mesopic conditions. Both a scotopic red (stimulus central wavelength 627 nm) and scotopic blue (stimulus central wavelength 550 nm) test modalities are available with the Scotopic model. Both modalities employ specific luminance scales and do not allow comparison with reference normal values.

Device Class : 1

Duns Number: 338702316

Premarket Exempt : No

Product Code : HPT

Prescription Use : Yes

Device Count : 1

EIDON - 08053677040062 Catalog Number : AINEUME001

Device Description : RETIA is a scanning ophthalmoscope which uses infrared and blue light to obtain RETIA is a scanning ophthalmoscope which uses infrared and blue light to obtain confocal infrared reflectance images and fluorescence images of the retina.

Device Class : 2

Duns Number: 338702316

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

EIDON - 08053677040079 Catalog Number : AIFLUME001

Device Description : EIDON AF (Eidon from Greek eidou, “to see” and AF, AutoFluorescence) is a scanni EIDON AF (Eidon from Greek eidou, “to see” and AF, AutoFluorescence) is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal infrared reflectance images, confocal visible reflectance images of the retina and fluorescence images of the retina, without pharmacological dilation.EIDON is a standalone device.

Device Class : 2

Duns Number: 338702316

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

RETIA 2 - 08053677040086 Catalog Number : AINEUME002

Device Description : The CenterVue Retia 2 Camera is intended for taking digital autofluorescence ima The CenterVue Retia 2 Camera is intended for taking digital autofluorescence images of the human retina with and without use of a mydriatic agent to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.

Device Class : 2

Duns Number: 338702316

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

EIDON - 08053677040093 Catalog Number : APFLAOP100

Device Description : The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and auto-fluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent.

Device Class : 2

Duns Number: 338702316

Premarket Exempt : No

Product Code : MYC, HKI

Prescription Use : Yes

Device Count : 1

DRSplus - 08053677040116 Catalog Number :

Device Description : The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a mydriatic agent.

Device Class : 2

Duns Number: 338702316

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

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