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iRes

by iVis Technologies S.r.l. Italy EUDAMED

Ref AX002, AX003, NX001

EMDN Z12011001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-AX002TK Basic UDI-DIDate29 Nov 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
AX002, AX003, NX001
Primary DI / UDI-DI
D-AX002TK, D-NX001XY
Basic UDI-DI
B-AX002TK, B-NX001XY
EMDN Code
Z12011001 Excimer surgical laser
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000016859

Other devices from iVis Technologies S.r.l.

See all devices from iVis Technologies S.r.l. →

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 (2)

  • EUDAMED e19123a3-8ffd-4d75-9c06-d624c61cad45 61 fields · synced 22 Oct 2026
  • EUDAMED f553551c-bbb7-4828-8bed-9abd1e7f1c23 61 fields · synced 18 May 2026