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Automated Visual Acuity Test [AVAT]

by Digital Life Line Pte Ltd

Ref AVAT01-AModel AVAT01

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8881300527AVAT9F Basic UDI-DIDate23 Jan 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Automated Visual Acuity Test [AVAT]
Model / Reference
AVAT01, AVAT01-A
Primary DI / UDI-DI
08881300527075
Basic UDI-DI
8881300527AVAT9F
Direct Marketing DI
08881300527075
EMDN Code
Z12120119 Ophthalmological treatment units
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
SG-MF-000045643
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Digital Life Line Pte Ltd

  • Avat

    Class I

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No