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Aevo System

by smilesonica.com Canada EUDAMED

Ref A32000Model A30000

EMDN Q010499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number627843493976AEVOSYSTEM5Y Basic UDI-DIDate30 Apr 2024RegisteredStatusActive

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
A30000, A32000
Primary DI / UDI-DI
06278434939768
Basic UDI-DI
627843493976AEVOSYSTEM5Y
Direct Marketing DI
06278434939768
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
CA-MF-000027146
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from smilesonica.com

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 658ce635-595b-4c6a-a30d-35c1b0d5aa5c 61 fields · synced 22 Oct 2026