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NuvoAir Home

by NuvoAir AB Sweden EUDAMED

Ref NVH-01

EMDN Z12150101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07350002630051 Basic UDI-DIDate13 May 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 22 Oct 2026

Model / Reference
NVH-01
Primary DI / UDI-DI
07350002630051
Basic UDI-DI
B-07350002630051
EMDN Code
Z12150101 Clinical/diagnostic spirometers
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000005645

Other devices from NuvoAir AB

  • Air Next

    Class IIa

  • Air Next

    Class IIa

  • Air Next

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f54ae037-6a4a-4cd3-b9fb-63a2b25bb9ce 61 fields · synced 22 Oct 2026