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Nebu-Mist

by Buona Spa Società Benefit EUDAMED

Active European Union

Ref 3064A1Model 3064

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80327496530640000000000DF Basic UDI-DIDate18 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Spray-Sol
Model / Reference
3064, 3064A1
Primary DI / UDI-DI
08032749653720
Basic UDI-DI
80327496530640000000000DF
EMDN Code
R060101 Cold nebulisation systems
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
IT-MF-000014415

Other devices from Buona Spa Società Benefit

See all devices from Buona Spa Società Benefit →

Properties

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