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Basic Emergency Kit - without manual bag (CM)

by Noxtec Development S.L. Spain EUDAMED

Ref P001079

EMDN R020108

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437023061NTXEmergKitsQM Basic UDI-DIDate28 Jul 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

Device Name
NTXEmergencyKits
Model / Reference
P001079
Primary DI / UDI-DI
08437023061275
Basic UDI-DI
8437023061NTXEmergKitsQM
EMDN Code
R020108 Respiratory gas monitoring and sampling circuits and kits
Device Class
Class IIa
Medical Purpose
The emergency kit is intended to provide immediate access to compatible CE-marked medical devices required to connect a nitric oxide delivery system to a ventilator and patient interface during critical care interventions. It is designed to facilitate rapid setup and support the timely administration of inhaled nitric oxide therapy. The kit does not introduce a new intended medical purpose and is limited to facilitating the combined emergency use of the included devices within their specified intended uses.

Manufacturer details

EUDAMED SRN
ES-PR-000045101

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Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED a0a9a125-8647-4f38-97ed-894847b40d2e 61 fields · synced 24 Oct 2026