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Retinow

by Retinow Sağlık Teknolojileri ve ARGE Sanayi Anonim Şirketi

Ref RAI01-V01Model RAI01

Active European Union

CE MDR

Valid until

11 Feb 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SZUTEST Konformitätsbewertungsstelle GmbH

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 Number2975-MED-2504301 Date12 Feb 2025IssuedStatusActive expires 11 Feb 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2975-MED-2504301 Active

    Quality management system EU MDR

    Certifier
    SZUTEST Konformitätsbewertungsstelle GmbH 2975
    Issued
    12 Feb 2025
    Expires
    11 Feb 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Retinow AI (Cloud-based software for diagnosis of retinal disorders)
Model / Reference
RAI01, RAI01-V01
Primary DI / UDI-DI
08683845754011
Basic UDI-DI
8683845754RAI01KF
EMDN Code
Z12120192 Ophtalmology assessments and diagnosis instruments - medical device software
Device Class
Class IIb
Special Device Type
Software
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000035284

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