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microQuark

by COSMED Srl

Ref C09061-01-99

microQuark (C09061-01-99) is a diagnostic spirometer (EU MDR Class IIa; FDA Class II) made by COSMED Srl, registered in EUDAMED on 4 Nov 2024 (Basic UDI-DI 805240018mQSH), cleared under FDA 510(k) K020745 on 2 Jan 2003 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 18052400180034), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K020745↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805240018mQSH Basic UDI-DI 18052400180034UDI-DIDate4 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number18052400180034 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK020745 Date2 Jan 2003IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805240018mQSH registered 4 Nov 2024 Active
  • FDA 510(k) K020745 decided 2 Jan 2003 Active
  • FDA GUDID UDI-DI 18052400180034 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K020745
  2. Listed FDA GUDID 18052400180034
  3. Registered EUDAMED 805240018mQSH

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
microQuark EUDAMED
Cosmed GUDID
Generic name
Diagnostic spirometer, professional
Model / reference
C09061-01-99 EUDAMED
microQuark GUDID
Primary DI / UDI-DI
18052400180034
Basic UDI-DI
805240018mQSH
Direct marketing DI
18052400180034
510(k) Number
FDA product code
BTY, BZC
EMDN code
Z12150101 Clinical/diagnostic spirometers
GMDN term
Diagnostic spirometer, professional
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.1890, 868.1880
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
C09061-01-99
GUDID
microQuark
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
IT-MF-000023488

Similar devices in this category

Other devices filed under CLINICAL/DIAGNOSTIC SPIROMETERS.

Other devices from COSMED Srl

See all devices from COSMED Srl →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)