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Aco Smartcare

by Aco Healthcare Co., Ltd. Taiwan EUDAMED

Ref Aco-Apa-C62Model C62, L154, neo C62, neo L154, neo L187, neo P42, neo P3H

EMDN Z11040106

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471989096ApacheDU Basic UDI-DIDate27 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Aco Apache Ultrasound Probe
Model / Reference
C62, L154, neo C62, neo L154, neo L187, neo P42, neo P3H, Aco-Apa-C62
Primary DI / UDI-DI
04719890960016
Basic UDI-DI
471989096ApacheDU
Direct Marketing DI
04719890960016
EMDN Code
Z11040106 Handheld ultrasound scanners
Device Class
Class IIa
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 a54c9681-0b4b-4081-8a0e-c1770d8d6c51 61 fields · synced 24 Oct 2026