Skip to content

Amis*pacs Flexserver G2

by ICZ.HEA a.s. Czech Republic EUDAMED

Ref 00003850

EMDN Z110603

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08594059060013 Basic UDI-DIDate8 Dec 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
00003850
Primary DI / UDI-DI
08594059060013
Basic UDI-DI
B-08594059060013
EMDN Code
Z110603 Picture archiving and communication systems
Device Class
Class IIb
Special Device Type
-1192
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000001703

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 0a284189-2465-4f42-bb6f-32c1d91bd8c6 61 fields · synced 22 Oct 2026