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MiniBox+

by Pulmone Advanced Medical Devices, Ltd.

Ref PUO-MiniBox+Model Lung Volume Measurement Testing

MiniBox+ is a device classified as Class IIa in the EU and Class II in the US made by Pulmone Advanced Medical Devices, Ltd., registered in EUDAMED on 20 Mar 2026 (Basic UDI-DI 07290016675MiniBox+8B), cleared under FDA 510(k) K161295 on 21 Oct 2016 and listed in FDA GUDID since 27 Jan 2017 (UDI-DI 07290016675016), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161295

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07290016675MiniBox+8B Basic UDI-DI 07290016675016UDI-DIDate20 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016675016 UDI-DI Date27 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK161295 Date21 Oct 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 07290016675MiniBox+8B registered 20 Mar 2026 Active
  • FDA 510(k) K161295 decided 21 Oct 2016 Active
  • FDA GUDID UDI-DI 07290016675016 listed 27 Jan 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161295
  2. Listed FDA GUDID 07290016675016
  3. Registered EUDAMED 07290016675MiniBox+8B

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  • Withdrawn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

Generic name
Diagnostic spirometer, professional
Model / reference
Lung Volume Measurement Testing EUDAMED
PUO-MiniBox+ EUDAMED
MiniBox+ GUDID
Primary DI / UDI-DI
07290016675016
Basic UDI-DI
07290016675MiniBox+8B
Direct marketing DI
07290016675016
510(k) Number
FDA product code
BZG, BZC
EMDN code
Z12159099 Various pneumology and respiratory physiopathology instruments - other
GMDN term
Diagnostic spirometer, professional
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.1840, 868.1880
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Lung Volume Measurement Testing
PUO-MiniBox+
GUDID
MiniBox+
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: Pulmonary function analysis system, adultDiagnostic spirometer, professional

Similar devices in this category

Other devices filed under VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS.

Other devices from Pulmone Advanced Medical Devices, Ltd.

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)