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NeuViz ACE

by Neusoft Medical Systems Co., Ltd. China EUDAMED

Ref none

EMDN Z11030603

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6970167440000000000000034 Basic UDI-DIDate4 Feb 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

Device Name
Multi-Slice CT Scanner System
Model / Reference
none
Primary DI / UDI-DI
06970167440329
Basic UDI-DI
6970167440000000000000034
EMDN Code
Z11030603 Computed tomographs - 16 layers or more but less than 64 layers
Device Class
Class IIb
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000011819
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Neusoft Medical Systems Co., Ltd.

See all devices from Neusoft Medical Systems Co., Ltd. →

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 7000bd12-c46e-476d-b0d6-8923c4ab902b 61 fields · synced 22 Oct 2026