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Aco Smartcare

by Aco Healthcare Co., Ltd. Taiwan EUDAMED

Ref Aco-Apa-iOSModel Apache App iOS, Apache App Android

EMDN Z11040192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471989096ApacheAppLM Basic UDI-DIDate20 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Apache App iOS, Apache App Android, Aco-Apa-iOS
Primary DI / UDI-DI
04719890960092
Basic UDI-DI
471989096ApacheAppLM
EMDN Code
Z11040192 Ultrasound scanners - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
TW-MF-000034057
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Aco Healthcare Co., Ltd.

See all devices from Aco Healthcare Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED b0432141-adba-4734-a2a7-ae23c5be97ee 61 fields · synced 22 Oct 2026