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Macula Explorer

by Altris Inc. United States EUDAMED

Ref 1Model Macula Explorer v1.0

EMDN Z12120282

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08600098265MacEx5N Basic UDI-DIDate27 May 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

Model / Reference
Macula Explorer v1.0, 1
Primary DI / UDI-DI
08600098265101
Basic UDI-DI
08600098265MacEx5N
EMDN Code
Z12120282 Therapeutic and surgical ophtholmological treatments instruments - software accessories
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000043686
Authorised representative
ALTRIS EUROPE, SOCIEDAD LIMITADA ES-AR-000043669

Other devices from Altris, Inc.

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 b98b9535-6d36-48d5-8118-bfb73498b0fd 61 fields · synced 22 Oct 2026