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Micro+

by Bedfont Scientific Ltd

Ref MICROADVModel Smokerlyzer

Micro+ (MICROADV) 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 506024686SM017H), cleared under FDA 510(k) K082315 on 1 Feb 2010 and listed in FDA GUDID since 12 Mar 2020 (UDI-DI 05060246860047), 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) K082315

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 Number506024686SM017H Basic UDI-DI 05060246860047UDI-DIDate12 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060246860047 UDI-DI Date12 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK082315 Date1 Feb 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506024686SM017H registered 12 Feb 2026 Active
  • FDA 510(k) K082315 decided 1 Feb 2010 Active
  • FDA GUDID UDI-DI 05060246860047 listed 12 Mar 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082315
  2. Listed FDA GUDID 05060246860047
  3. Registered EUDAMED 506024686SM017H

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  • Withdrawn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
Micro+ EUDAMED
Smokerlyzer GUDID
Generic name
Carbon monoxide breath analyser
Device name
PiCO
Model / Ref / Catalog
Smokerlyzer, MICROADV, Micro+
Primary DI / UDI-DI
05060246860047
Basic UDI-DI
506024686SM017H
Direct marketing DI
05060246860047
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
Slovakia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Smokerlyzer
MICROADV
GUDID
Micro+
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
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)