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Smart-4

by Avan Teb Iran EUDAMED

Ref SMART-4

EMDN Z12010902

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06262216600144 Basic UDI-DIDate4 Oct 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

Device Name
SMART-4 Electrosurgical Unit
Model / Reference
SMART-4
Primary DI / UDI-DI
06262216600144
Basic UDI-DI
B-06262216600144
EMDN Code
Z12010902 Electrosurgical units (esu) for general use
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IR-MF-000059597
Authorised representative
Trionara Technologies AB SE-AR-000005045

From the manufacturer

Manufacturer's product page: Smart-4

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 9d7c4018-bd3f-4e7d-ace2-0b749c3db9e9 61 fields · synced 23 Oct 2026