Skip to content

EasyOne Air Diagnostic Spirometer 2500

by NDD Medizintechnik AG

Ref 2500-2, 2500

EasyOne Air Diagnostic Spirometer 2500 is a diagnostic spirometer (EU MDR Class IIa; FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by NDD Medizintechnik AG, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 764014219SpirometerBS), cleared under FDA 510(k) K161536 on 5 Jan 2017 and listed in FDA GUDID since 6 Mar 2017 (UDI-DI 07640142190431), 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) K161536

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014219SpirometerBS Basic UDI-DI Date13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640142190431 UDI-DI Date6 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK161536 Date5 Jan 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 764014219SpirometerBS registered 13 May 2026 Active
  • FDA 510(k) K161536 decided 5 Jan 2017 Active
  • FDA GUDID UDI-DI 07640142190431 listed 6 Mar 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161536
  2. Listed FDA GUDID 07640142190431
  3. Registered EUDAMED 764014219SpirometerBS

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  • Withdrawn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
EasyOne Air EUDAMED
EasyOne Air Spirometer EUDAMED
EasyOne Air Diagnostic Spirometer GUDID
Generic name
Diagnostic spirometer, professional
Device name
Spirometry Family
Flow Sensor
Model / reference
2500, 2500-2
Primary DI / UDI-DI
07640142190431, 07640142190875
Basic UDI-DI
764014219SpirometerBS, 764014219FlowSensorRW
Direct marketing DI
07640142190431
07640142190875
510(k) Number
FDA product code
BZG
EMDN code
Z12150180 Spirometry instruments - hardware accessories
GMDN term
Diagnostic spirometer, professional
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.1840
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Diagnostic spirometer, professional

Cleared under the same submission (K161536)

Similar devices in this category

Other devices filed under SPIROMETRY INSTRUMENTS.

Other devices from NDD Medizintechnik AG

See all devices from NDD Medizintechnik AG →

Properties

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