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by Inosystems France EUDAMED

Ref IN000296

EMDN Z1203019002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376033338INOTHERAPYEF Basic UDI-DIDate2 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Nitric Oxide Delivery and Monitoring Device
Model / Reference
IN000296
Primary DI / UDI-DI
03760333380916
Basic UDI-DI
376033338INOTHERAPYEF
EMDN Code
Z1203019002 Nitric oxide dispensers
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000011282

Other devices from Inosystems

See all devices from Inosystems →

Properties & raw data

Show properties, registry sources and raw records
  • CMR Substance
  • Administering Medicine
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED d64669dc-ad8a-451a-81c5-8f68a0aa137a 61 fields · synced 23 Oct 2026