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Optomep

by SMT4V Researching Sl Spain EUDAMED

Ref OM

EMDN Z1212012092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-84370263851014VN7 Basic UDI-DIDate12 Mar 2026RegisteredStatusActive

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
OM
Primary DI / UDI-DI
D-84370263851014VN7
Basic UDI-DI
B-84370263851014VN7
EMDN Code
Z1212012092 Instruments for the assessment of visual functionality - medical device software
Device Class
Class I
Special Device Type
-1192
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000042932

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 8093176f-a2f9-455f-8b0e-3d301e944079 61 fields · synced 22 Oct 2026