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Aevo Oral Ultrasound gel

by smilesonica.com Canada EUDAMED

Ref C4004Model A30000

EMDN V80

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

Device Name
Aevo System
Model / Reference
A30000, C4004
Primary DI / UDI-DI
00627843493990
Basic UDI-DI
627843493976AEVOSYSTEM5Y
Direct Marketing DI
00627843493990
EMDN Code
V80 Clinical use accessories not included in other classes
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 62d7f567-d280-436d-8589-f97a51cf62e7 61 fields · synced 22 Oct 2026