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iCOquit

by Bedfont Scientific Ltd

Ref ICOQUIT

iCOquit 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 12 Feb 2026 (Basic UDI-DI 506024686SMI016V), cleared under FDA 510(k) K211918 on 21 Dec 2021 and listed in FDA GUDID since 6 Jan 2022 (UDI-DI 05060246860429), 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) K211918

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 Number506024686SMI016V Basic UDI-DI 05060246860429UDI-DIDate12 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060246860429 UDI-DI Date6 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211918 Date21 Dec 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506024686SMI016V registered 12 Feb 2026 Active
  • FDA 510(k) K211918 decided 21 Dec 2021 Active
  • FDA GUDID UDI-DI 05060246860429 listed 6 Jan 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K211918
  2. Listed FDA GUDID 05060246860429
  3. Registered EUDAMED 506024686SMI016V

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  • Withdrawn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

Trade name
iCOquit EUDAMED
iCO Quit Smokerlyzer GUDID
Generic name
Carbon monoxide breath analyser
Model / Ref / Catalog
ICOQUIT, iCO Quit
Primary DI / UDI-DI
05060246860429
Basic UDI-DI
506024686SMI016V
510(k) Number
FDA product code
CCJ
EMDN code
Z1203020402 Carbon monoxide analysers
GMDN term
Carbon monoxide breath analyser
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.1430
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ICOQUIT
GUDID
iCO Quit
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
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)