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IXanner®

by Tishyas Medical Device Development Solutions Private Limited EUDAMED

Active European Union

Ref IXanner® AEAR-MP90004Model IXanner® AEARMP90004 IXanner® 7vn M model-MP90008 IXanner® 7vn μ Model-MP90013 IXanner® VET M model-MP90014 IXanner® VET μ Model-MP90015

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8908026338IXanner01E5 Basic UDI-DIDate18 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
IXanner®
Model / Reference
IXanner® AEAR MP90004 IXanner® 7vn M model-MP90008 IXanner® 7vn μ Model-MP90013 IXanner® VET M model-MP90014 IXanner® VET μ Model-MP90015, IXanner® AEAR-MP90004
Primary DI / UDI-DI
08908026338003
Basic UDI-DI
8908026338IXanner01E5
EMDN Code
Z12120113 Ophthalmometers
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
IN-MF-000046701
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

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