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Sinapse Diagnostics

by SIA AKA Sinapse Latvia EUDAMED

Ref SINAPSEDX-1.0.0

EMDN V92

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number475105198SINAPSEDXSC Basic UDI-DIDate16 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
SINAPSEDX-1.0.0
Primary DI / UDI-DI
04751051980020
Basic UDI-DI
475105198SINAPSEDXSC
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Market of Registration
Latvia

Manufacturer details

EUDAMED SRN
LV-MF-000052443

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 675616ca-7183-41e4-aacb-4790b9875369 61 fields · synced 23 Oct 2026