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Bone Marrow Smear Analysis Software - aetherAI Hema

by aetherAI Co., Ltd. Taiwan EUDAMED

Ref aetherAI Hema EMDN W0202010292

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04719884160323 Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Bone Marrow Smear Analysis Software
Model / Reference
aetherAI Hema
Primary DI / UDI-DI
04719884160323
Basic UDI-DI
B-04719884160323
EMDN Code
W0202010292 Limited panel cell counting analysers - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
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 (9)
  • 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

Sources (1)

  • EUDAMED 32182d7c-8ed5-4f17-bdc8-8a83894d11ff 61 fields · synced 25 Oct 2026