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Kit Differential Pressure for 15mm with humidifier

by Noxtec Development S.L. EUDAMED

Active European Union

Ref P000704

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437023061NoxtecKits7Y Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
NTX1000Kits
Model / Reference
P000704
Primary DI / UDI-DI
08437023061084
Medical Purpose
The procedure pack is intended to assemble CE-marked medical devices to enable the connection of a nitric oxide delivery system to a ventilator and patient interface, in order to support the administration of inhaled nitric oxide therapy. The procedure pack does not introduce a new intended medical purpose and is limited to facilitating the combined use of the included devices within their specified intended uses.

Manufacturer details

EUDAMED SRN
ES-PR-000045101

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