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Digital Pathology System

by aetherAI Co., Ltd. Taiwan EUDAMED

Ref aetherSlide

EMDN W0202050392

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number04719884160112B Basic UDI-DIDate27 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Digital Pathology System
Model / Reference
aetherSlide
Primary DI / UDI-DI
04719884160118
Basic UDI-DI
04719884160112B
Direct Marketing DI
04719884160118
EMDN Code
W0202050392 Laboratory instruments for microscopic investigations - IVD medical device software
Device Class
Class A
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000038521
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from aetherAI Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 97b830d1-0a2f-40a6-a10e-b9b0316c7f8a 61 fields · synced 22 Oct 2026