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Kit NTX3000 for 10mm

by Noxtec Development S.L. Spain EUDAMED

Ref P000725

EMDN V9099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437023061NTX3000KitsLT 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 23 Oct 2026

Device Name
NTX3000Kits
Model / Reference
P000725
Primary DI / UDI-DI
08437023061206
Basic UDI-DI
8437023061NTX3000KitsLT
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class IIa
Medical Purpose
The procedure pack is intended to assemble CE-marked medical devices to enable the connection of a nitric oxide monitoring system to a ventilator and patient interface. 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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See all devices from NOXtec Development S.L. →

Properties & raw data

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

Sources (1)

  • EUDAMED 89221c44-66f9-4b96-88fb-facc93d3394b 61 fields · synced 23 Oct 2026