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Niox Pro

by Niox Ab EUDAMED

Active European Union

Ref 20-1000

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberIX 1379539-1 Date6 Jul 2026IssuedStatusActive expires 11 Jun 2031

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Model / Reference
20-1000
Primary DI / UDI-DI
07350047030724
Basic UDI-DI
735004703NIOXPROMZ
Direct Marketing DI
07350047030724
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class B
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000010044

Other devices from Niox Ab

See all devices from Niox Ab →

Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No