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Dafne

by Novavision Group Italy EUDAMED

Ref 380800000327Model Electrostimulation and Photostimulation Medical Device

EMDN Z12040203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-08059340930043 Basic UDI-DIDate28 Nov 2025RegisteredStatusActive
European UnionCE/MDD NumberB-08059340930043 Basic UDI-DIDate28 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Novaclinical Dafne
Model / Reference
Electrostimulation and Photostimulation Medical Device, 380800000327
Primary DI / UDI-DI
08059340930043
Basic UDI-DI
B-08059340930043, 805934093N01203T
Direct Marketing DI
08059340930043
EMDN Code
Z12040203, Z12040299
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000024333

Other devices from Novavision Group

See all devices from Novavision Group →

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 (2)

  • EUDAMED 5e4f6e99-9dff-4885-8d9b-96548f1d9fb4 61 fields · synced 22 Oct 2026
  • EUDAMED 08059340930043|805934093N01203T 61 fields · synced 19 May 2026