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Spirolyser Q13

by FIM Medical 2 variants

Ref FF1037Model Spirolyser Q13

Spirolyser Q13 (FF1037) is a pulmonary function analysis system (EU MDD Class IIa; FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Fim Medical, registered in EUDAMED on 16 Feb 2026 (Basic UDI-DI 376025345FF1037TL), cleared under FDA 510(k) K161676 on 20 Oct 2016 and listed in FDA GUDID since 4 May 2017 (UDI-DI 03760253450003), active as of 24 Oct 2026.

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

CE MDR CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161676↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number376025345FF1037TL Basic UDI-DI 03760253450003UDI-DIDate16 Feb 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number376025345FF1037TL Basic UDI-DI 03760253450003UDI-DIDate16 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760253450003 UDI-DI Date4 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK161676 Date20 Oct 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 376025345FF1037TL registered 16 Feb 2026 Active· +1 more in the status table
  • FDA 510(k) K161676 decided 20 Oct 2016 Active
  • FDA GUDID UDI-DI 03760253450003 listed 4 May 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161676
  2. Listed FDA GUDID 03760253450003
  3. Registered EUDAMED 376025345FF1037TL

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
Spirolyser Q13 EUDAMED
Spirolyser GUDID
Generic name
Pulmonary function analysis system, adult
Model / reference
Spirolyser Q13 EUDAMED
FF1037 EUDAMED
Q13 GUDID
Primary DI / UDI-DI
03760253450003
Basic UDI-DI
376025345FF1037TL, B-03760253450003
Direct marketing DI
03760253450003
510(k) Number
FDA product code
BZG
EMDN code
Z12150101 Clinical/diagnostic spirometers
GMDN term
Pulmonary function analysis system, adult
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.1840
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Spirolyser Q13
FF1037
GUDID
Q13
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
FR-MF-000017090

Similar devices in this category

Other devices filed under CLINICAL/DIAGNOSTIC SPIROMETERS.

Other devices from Fim Medical

See all devices from Fim Medical →

Properties

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