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NIOX VERO Handle

by Circassia AB

Ref 12-1010

NIOX VERO Handle (12-1010) is a nitrogen monoxide analyser (EU IVDR Class B; FDA Class II; FDA product code MXA, System,Test,Breath Nitric Oxide) made by Circassia AB, registered in EUDAMED on 19 Jun 2026 (Basic UDI-DI 735004703NIOXHANDLE6R) with CE/IVDR certificate IX 1379539-1 valid until 11 Jun 2031, cleared under FDA 510(k) K133898 on 6 Nov 2014 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 07350047030175), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

11 Jun 2031

CE IVDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

510(k) K133898

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED NumberIX 1379539-1 Date6 Jul 2026IssuedStatusActive expires 11 Jun 2031
United StatesGUDID listing GUDID Number07350047030175 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK133898 Date6 Nov 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 735004703NIOXHANDLE6R registered 19 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K133898 decided 6 Nov 2014 Active
  • FDA GUDID UDI-DI 07350047030175 listed 21 Sep 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

5 dated events

  1. Cleared FDA 510(k) K133898
  2. Listed FDA GUDID 07350047030175
  3. Registered EUDAMED 735004703NIOXHANDLE6R
  4. Certificate issued EUDAMED IX 1379539-1
  5. Certificate expires EUDAMED IX 1379539-1

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Niox
Generic name
Nitrogen monoxide analyser
Device name
NIOX Breathing Handle
Model / Ref / Catalog
12-1010, VERO Handle
Primary DI / UDI-DI
07350047030175
Basic UDI-DI
735004703NIOXHANDLE6R
Direct marketing DI
07350047030175
510(k) Number
FDA product code
MXA
EMDN code
W0201069080 Various rapid test chemistry / immunochemistry instruments - hardware accessories
GMDN term
Nitrogen monoxide analyser
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.3080
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
12-1010
GUDID
VERO Handle
Device classEUDAMED
Class B
GUDID
Class II

Device class is stated on each registry's own scale: Class B in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Nitrogen monoxide analyser

Cleared under the same submission (K133898)

and 8 more cleared under K133898

Similar devices

Also classified as Nitrogen monoxide analyser.

Similar devices in this category

Other devices filed under VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Circassia AB

See all devices from Circassia AB →

Properties

  • Near-patient testing
  • Professional testing
  • Prescription use
  • Serial number
  • Expiration date
Other properties (21, all answered No)