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Inhaled Nitric Oxide System

by Shenzhen Respomed Medical Technology Co. Ltd China EUDAMED

Ref eNO-200Model eNO-100, eNO-200, eNO-100Neo, eNO-200Neo, eNO-10, eNO-20

EMDN Z1203019002

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69762093106976209310124BG Basic UDI-DIDate4 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
eNO-100, eNO-200, eNO-100Neo, eNO-200Neo, eNO-10, eNO-20
Primary DI / UDI-DI
06976209313019
Basic UDI-DI
69762093106976209310124BG
Direct Marketing DI
06976209313019
EMDN Code
Z1203019002 Nitric oxide dispensers
Device Class
Class IIb
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000046707
Authorised representative
Ruiyi Healthcare GmbH DE-AR-000005962

Other devices from Shenzhen Respomed Medical Technology Co. Ltd

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED d4ac95e4-b1f0-4731-97a5-52baad5c6486 61 fields · synced 24 Oct 2026