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Smart Bolus

by Social Diabetes S.L. Spain EUDAMED

Ref SMARTBOLUS-01Model Smart Bolus Calculator

EMDN Z12040192

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-84370243300024 Basic UDI-DIDate5 May 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 23 Oct 2026

Model / Reference
Smart Bolus Calculator, SMARTBOLUS-01
Primary DI / UDI-DI
84370243300024
Basic UDI-DI
B-84370243300024
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class IIb
Special Device Type
-1192
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000019618

Other devices from Social Diabetes S.L.

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED cac12484-a1d0-4c1a-a576-bd05a9c5cfc5 61 fields · synced 23 Oct 2026