Development and manufacture of computerized pulmonary function diagnostics and chemiluminescence NO analyzers for clinical and research applications.

ECO MEDICS AG

Dürnten (Switzerland) · Hürth (Germany)New on Amplifa

Swiss AG (stock corporation)Legal form

Dürnten, CHHeadquarters & Manufacturing (ECO PHYSICS AG)

WorldwideSales via direct sales and exclusive distributors

About ECO MEDICS

ECO MEDICS AG, headquartered in Dürnten, Switzerland, develops and markets computerized pulmonary diagnostic products for infants (from 3 kg body weight), children and adults – for routine clinical use and scientific research. The product range includes the EXHALYZER devices for pulmonary function testing (nitrogen washout, FRC/LCI, spirometry), the ANALYZER CLD 88 series with DENOX 88 for FeNO measurements based on the chemiluminescence principle, as well as analyzers for liquid NO samples from biomedical and pharmaceutical applications. The combination of patented ultrasonic flow measurement and precise gas analysis, in particular nitric oxide, enables comprehensive measurement of pulmonary parameters. Manufacturing is performed by the sister company ECO PHYSICS AG at the same location, which is audited to EN ISO 9001:2015 and EN ISO 13485:2016. Products are sold via direct sales in selected markets as well as through exclusive distributors worldwide to hospitals, clinics, pulmonary function laboratories and research institutes; all measurements are controlled and evaluated via the SPIROWARE software.

Site: Dürnten
Processes: Design, development and manufacture of gas analyzers for medical diagnostics (pulmonology),, Design, manufacture and final inspection of EXHALYZER D, ANALYZER CLD 88 series with DENOX 88, Manufacture of pulmonary diagnostic products according to EN ISO 9001:2015 and EN ISO 13485:2016, Application support and research assistance, Technical support and service, Sales via direct sales and exclusive distributors, Training/presentations at trade fairs and events, Export to reports or central data storage (e.g. hospital information systems) via SPIROWARE
Materials: Chemiluminescence detection, Ultrasonic flow measurement, Nitrogen Washout (SBW/MBW)
Certificates: EN ISO 9001:2015, EN ISO 13485:2016, MDSAP (ISO 13485:2016), MDD 93/42/EEC (Annex II), EU MDR 2017/745 (Annex IX, QMS), EU MDR 2017/745 (QMS, Annex IX), MDSAP (ISO 13485:2016, USA FDA)
Industries: Medical technology / Pulmonology, Hospitals and clinics, Pulmonary function laboratories, Research institutes, Biomedical and pharmaceutical applications, Biomedical and pharmaceutical applications (liquid NO analysis)

01
Research & Development
02
Design and engineering
03
Manufacturing and final inspection by ECO PHYSICS AG (Dürnten)
04
Certification according to MDD/MDR
05
Sales (direct sales and distributors)
06
Support, service and application support

Measurement Technology & Processes

CLD

Chemiluminescence detection

Measurement principle of the ANALYZER CLD 88 series for FeNO – the detection method for exhaled nitric oxide recommended by the ATS/ERS guidelines.

US-Flow

Ultrasonic flow measurement

Patented measurement method which, together with gas analysis, enables comprehensive determination of pulmonary parameters.

N2-WO

Nitrogen Washout (SBW/MBW)

Method for detecting ventilation inhomogeneity and small airway diseases such as asthma, cystic fibrosis and COPD.

Locations

Dürnten

Headquarters (Corporate Headquarter ECO MEDICS AG / ECO PHYSICS AG) with development, manufacturing and final inspection

Hürth

EU Authorized Representative (ECO Physics GmbH) with sales and technical support

Instruments

**ANALYZER CLD 88 sp – FeNO analyzer**Chemiluminescence · Pulmonology

**EXHALYZER D – Pulmonary function diagnostics**N2-Washout · Pulmonology

**DENOX 88**NO zero-gas generator · Medical technology

**ANALYZER CLD 88 – Liquid NO analysis**Chemiluminescence · Biomedical/Pharma

Inside the production

Measurement parameters of the ECO MEDICS instruments

Industries

Medical technology / PulmonologyHospitals and clinicsPulmonary function laboratoriesResearch institutesBiomedical and pharmaceutical applicationsBiomedical and pharmaceutical applications (liquid NO analysis)

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Design, development and manufacture of gas analyzers for medical diagnostics (pulmonology),Assembly	–	–	–	–	–
Design, manufacture and final inspection of EXHALYZER D, ANALYZER CLD 88 series with DENOX 88Assembly	–	–	–	–	–
Manufacture of pulmonary diagnostic products according to EN ISO 9001:2015 and EN ISO 13485:2016Assembly	–	–	–	–	–

Additional services

Application support and research assistanceTechnical support and serviceSales via direct sales and exclusive distributorsTraining/presentations at trade fairs and eventsExport to reports or central data storage (e.g. hospital information systems) via SPIROWARE

Quality & Certificates

The products are manufactured by ECO PHYSICS AG in Dürnten, which is continuously audited according to EN ISO 9001:2015 and EN ISO 13485:2016. Medical devices are certified under EU MDR 2017/745 (NB 0483, mdc); for the US market there is an MDSAP certification through TÜV SÜD America.

Evidence	Dürnten
EN ISO 9001:2015
EN ISO 13485:2016
EU MDR 2017/745 (QMS, Annex IX)
MDD 93/42/EEC (Annex II)
MDSAP (ISO 13485:2016, USA FDA)

History

2020
Issuance of the MDD certificate (Annex II, Directive 93/42/EEC) for EXHALYZER D and the ANALYZER CLD 88 series with DENOX 88 by mdc (NB 0483), valid until 2024-05-26.
2022
Issuance of the EU MDR QMS certificate (Annex IX) by mdc (NB 0483) for EXHALYZER D (Class IIa), valid until 2027-11-08.
2025
Renewal of the MDSAP certification (ISO 13485:2016) by TÜV SÜD America, valid until 2028-10-13.