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MIR FlowMIR

by Mir Medical International Research SpA 2 variants

Ref 910004Model Spirometry Accessories

MIR FlowMIR is an expiratory peak flow meter (EU MDR Class IIa; FDA Class I; FDA product code BYP, Mouthpiece, Breathing) made by Mir Medical International Research SpA, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 805299032TRB-RUJ7) and listed in FDA GUDID since 10 Sep 2024 (UDI-DI 08052990321834), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805299032TRB-RUJ7 Basic UDI-DI 08052990321834UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08052990321834 UDI-DI Date10 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805299032TRB-RUJ7 registered 21 May 2026 Active
  • FDA GUDID UDI-DI 08052990321834 listed 10 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08052990321834
  2. Registered EUDAMED 805299032TRB-RUJ7

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
FlowMIR Disposable Turbine EUDAMED
Mir GUDID
Generic name
Expiratory peak flow meter, digital
Model / reference
Spirometry Accessories EUDAMED
910004 EUDAMED
FlowMIR GUDID
Primary DI / UDI-DI
08052990321834
Basic UDI-DI
805299032TRB-RUJ7
FDA product code
BYP
EMDN code
Z12150180 Spirometry instruments - hardware accessories
GMDN term
Expiratory peak flow meter, digital
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5620
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
Spirometry Accessories
910004
GUDID
FlowMIR
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Expiratory peak flow meter, digital

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)