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S-Maia

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref ACMASME002

by Centervue S.p.a.

Identity

Trade Name
MAIA FDA UDI
Generic Name
Perimeter, automatic FDA UDI
Device Name
S-MAIA EUDAMED
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. FDA UDI
Model / Reference
ACMASME002 EUDAMED
S-MAIA FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
ACMASME002 FDA UDI
Primary DI / UDI-DI
08053677040055 EUDAMEDFDA UDI
Basic UDI-DI
B-08053677040055 EUDAMED
510(k) Number
K153181 FDA UDI
FDA Product Code
HPT FDA UDI
EMDN Code
Z1212012003 PERIPHERAL VISION ANALYSERS EUDAMED
GMDN Term
Perimeter, automatic FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
886.1605 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Perimeter, automatic

S-Maia by Centervue S.p.a. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Perimeter, automatic.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Centervue S.p.a.
EUDAMED SRN
IT-MF-000017082

Sources (3)

  • EUDAMED 458bc347-d36f-4b4d-98b9-113f426f27a7 61 fields · synced Jun 20, 2026
  • FDA UDI 7b5d9ca7-9a8f-4b28-a1f1-f6405ef7467d 35 fields · synced May 30, 2026
  • FDA 510(k) K153181 1 fields · synced May 18, 2026