Skip to the page
Get started – free

Data / Medical devices / Switzerland / NDD Medizintechnik AG

NDD Medizintechnik AG: FDA-registered device maker in Zurich, Switzerland, 8 510(k) clearances

NDD Medizintechnik AG is registered with the FDA (registration 9614485) in Zurich, Switzerland. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 19, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch NDD Medizintechnik AG
FDA registration number
9614485
FEI number
3002673652
Address
Technoparkstrasse 1, Zurich, Switzerland, CH-8005
Owner or operator
ndd Medizintechnik AG (9040235)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
November 20, 2007
Registered through
2026
Brand names listed
Easy on-PC Spirometer, EasyOne Air Spirometer, EasyOne Filter FT, EasyOne Filter SP, EasyOne FlowTube, EasyOne Pro LAB Respiratory Analysis System, EasyOne Pro Respiratory Analysis System, EasyOne Pro/Pro LAB and more

Devices it lists

DeviceProduct codeClassRoleSource
Calculator, Predicted Values, Pulmonary FunctionBTY2Complaint file establishment, Specification developeraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Complaint file establishment, Specification developeraccessdata.fda.gov
Mouthpiece, BreathingBYP1Complaint file establishment, Specification developeraccessdata.fda.gov
Spirometer, DiagnosticBZG2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Transducer, Gas FlowBXP1Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 19, 2023K230178EasyOne Sky SpirometerBZGSubstantially EquivalentNdd Medizintechnik AGaccessdata.fda.gov
November 22, 2022K221250EasyOne FilterCAHSubstantially EquivalentNdd Medizintechnik AGaccessdata.fda.gov
February 22, 2017K161534EasyOne Pro Respiratory Analysis SystemBTYSubstantially EquivalentNdd Medizintechnik AGaccessdata.fda.gov
January 5, 2017K161536EasyOne Air SpirometerBZGSubstantially EquivalentNdd Medizintechnik AGaccessdata.fda.gov
September 27, 2012K120635EASYONE PRO RESPIRATORY TESTING DEVICEBTYSubstantially EquivalentNdd Medizitechnik AGaccessdata.fda.gov
January 27, 2010K091428EASYONE PRO RESPIRATORY ANALYSIS SYSTEMBTYSubstantially EquivalentNdd Medizitechnik AGaccessdata.fda.gov
June 2, 2009K090034EASY ON-PC SPIROMETERBZGSubstantially EquivalentNdd Medizitechnik AGaccessdata.fda.gov
May 23, 2000K993921NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001BZGSubstantially EquivalentNdd Medical Technologiesaccessdata.fda.gov

Compare with other makers

Updated October 19, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.