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Mir

by Mir Medical International Research SpA

Ref 911003Model MIR053

Mir is an expiratory peak flow meter (EU MDR Class IIa; FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Mir Medical International Research SpA, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 805299032052-053D4), cleared under FDA 510(k) K122384 on 4 Oct 2012 and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 08052990320653), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122384

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805299032052-053D4 Basic UDI-DI 08052990320653UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08052990320653 UDI-DI Date25 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK122384 Date4 Oct 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805299032052-053D4 registered 21 May 2026 Active
  • FDA 510(k) K122384 decided 4 Oct 2012 Active
  • FDA GUDID UDI-DI 08052990320653 listed 25 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122384
  2. Listed FDA GUDID 08052990320653
  3. Registered EUDAMED 805299032052-053D4

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  • Withdrawn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
Minispir Light POST BD EUDAMED
Mir GUDID
Generic name
Expiratory peak flow meter, digital
Model / reference
MIR053 EUDAMED
911003 EUDAMED
MiniSpir spirometer Light POST BD Edition GUDID
Primary DI / UDI-DI
08052990320653
Basic UDI-DI
805299032052-053D4
510(k) Number
FDA product code
BZG
EMDN code
Z12150102 Peak flow spirometers
GMDN term
Expiratory peak flow meter, digital
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.1840
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MIR053
911003
GUDID
MiniSpir spirometer Light POST BD Edition
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.

Related devices

Category: Expiratory peak flow meter, digital

Cleared under the same submission (K122384)

and 8 more cleared under K122384

Similar devices in this category

Other devices filed under PEAK FLOW SPIROMETERS.

Other devices from Mir Medical International Research SpA

See all devices from Mir Medical International Research SpA →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)