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deepeye® TPS

by deepeye Medical GmbH Germany EUDAMED

Ref V1.x.x EMDN Z12129092

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number22M00025CRT02 - 22M00025SUP03 Date10 Aug 2026IssuedStatusActive expires 12 May 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 22M00025CRT02 - 22M00025SUP03 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 1912
    Issued
    10 Aug 2026
    Expires
    12 May 2030
    Reason
    Other

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
V1.x.x
Primary DI / UDI-DI
04262449580017
Basic UDI-DI
426244958deepeyeTPSE6
EMDN Code
Z12129092 Various ophtalmology instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000038153

Other devices from deepeye Medical GmbH

  • deepeye® TPS nAMD

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 6d13189a-cab8-49f6-a6c8-8c35be9f925e 61 fields · synced 22 Oct 2026