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NObreath

by Bedfont Scientific Ltd

Ref NOBREATH-V2

NObreath (NOBREATH-V2) is a device classified as Class IIa in the EU and Class II in the US made by Bedfont Scientific Ltd, registered in EUDAMED on 27 Jan 2026 (Basic UDI-DI 506024686NO016Q), cleared under FDA 510(k) K203695 on 17 Dec 2021 and listed in FDA GUDID since 6 Jan 2022 (UDI-DI 05060246860177), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K203695

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506024686NO016Q Basic UDI-DI 05060246860177UDI-DIDate27 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060246860177 UDI-DI Date6 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK203695 Date17 Dec 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506024686NO016Q registered 27 Jan 2026 Active
  • FDA 510(k) K203695 decided 17 Dec 2021 Active
  • FDA GUDID UDI-DI 05060246860177 listed 6 Jan 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K203695
  2. Listed FDA GUDID 05060246860177
  3. Registered EUDAMED 506024686NO016Q

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Nitric oxide breath analyser
Model / Ref / Catalog
NOBREATH-V2, NOBreath V2
Primary DI / UDI-DI
05060246860177
Basic UDI-DI
506024686NO016Q
Direct marketing DI
05060246860177
510(k) Number
FDA product code
MXA
EMDN code
Z12159006 Expirated gas analysers
GMDN term
Nitric oxide breath analyser
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
862.3080
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
NOBREATH-V2
GUDID
NOBreath V2
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
GB-MF-000010889
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)