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Easy on-PC 2700-3

by NDD Medizintechnik AG

Ref 2700-3

Easy on-PC 2700-3 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) K090034 on 2 Jun 2009 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07640142190301), 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) K090034

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 Number764014219SpirometerBS Basic UDI-DI 07640142190301UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640142190301 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK090034 Date2 Jun 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 764014219SpirometerBS registered 13 May 2026 Active
  • FDA 510(k) K090034 decided 2 Jun 2009 Active
  • FDA GUDID UDI-DI 07640142190301 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K090034
  2. Listed FDA GUDID 07640142190301
  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  • Withdrawn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
Easy on-PC
Generic name
Diagnostic spirometer, professional
Device name
Spirometry Family
Model / Ref / Catalog
2700-3
Primary DI / UDI-DI
07640142190301
Basic UDI-DI
764014219SpirometerBS
Direct marketing DI
07640142190301
510(k) Number
FDA product code
BZG
EMDN code
Z12150101 Clinical/diagnostic spirometers
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 (K090034)

Similar devices in this category

Other devices filed under CLINICAL/DIAGNOSTIC SPIROMETERS.

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)