Skip to content

Niox

by Niox Ab EUDAMED

Active European Union

Ref 12-1020

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735004703NIOXFILTERAW Basic UDI-DIDate18 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
NIOX Filter
Model / Reference
12-1020
Primary DI / UDI-DI
07350047030199
Basic UDI-DI
735004703NIOXFILTERAW
EMDN Code
R049001 Pulmonary function test filters
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000010044

Other devices from Niox Ab

  • Niox Vero

    IVD General

  • Niox

    Class I

  • Niox Pro

    Class B

  • Niox

    Class I

  • Niox

    Class I

  • Niox

    Class I

See all devices from Niox Ab →

Properties

Other properties (13)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No