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RESPINOR DXT Control Unit

by Respinor As Norway EUDAMED

Ref 970-0003 4.1

EMDN Z11049092

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number709005853DXTADL Basic UDI-DIDate10 Oct 2025RegisteredStatusActive

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
RESPINOR DXT Control Unit
Model / Reference
970-0003 4.1
Primary DI / UDI-DI
07090058530096
Basic UDI-DI
709005853DXTADL
Direct Marketing DI
07090058530096
EMDN Code
Z11049092 Various ultrasound instruments - medical device software
Device Class
Class IIa
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
NO-MF-000012955

Other devices from Respinor As

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 879a0917-bbf4-492f-81bb-7f4f050f7bc6 61 fields · synced 23 Oct 2026