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Geratherm Respiratory – Fertigung

Develops and manufactures diagnostic devices in Germany for spirometry, pulmonary function testing, and cardiopulmonary exercise testing.

Geratherm Respiratory Logo

Geratherm Respiratory GmbH

Bad KissingenNew on Amplifa

GmbH (HRB 5181, Amtsgericht Schweinfurt)Legal Form
>120 distribution partners on allDistribution
Production exclusively in GermanyManufacturing

About Geratherm Respiratory

Geratherm Respiratory GmbH, based in Bad Kissingen, develops and manufactures medical devices for pulmonary function diagnostics. The product portfolio includes spirometry devices (e.g., Spirostik Blueflow), pulmonary function testing (PFT) devices such as PFTstik, Bodystik, and Add-on CO Diffusion, as well as systems for cardiopulmonary exercise testing (CPET) such as Ergostik and Ambistik. All products run on the diagnostic software platform BLUE CHERRY®, which integrates various diagnostic functions into a common platform. Production takes place exclusively in Germany; particular emphasis is placed on intuitive operation and a hygiene concept for patient protection. The company supplies hospitals and medical facilities worldwide through a network of more than 120 distribution partners on all continents. The devices are CE marked according to MDR (EU 2017/745) and RoHS (2011/65/EU).

Site
Bad Kissingen
Processes
BLUE CHERRY® Diagnostic Software Platform, Certification via CE Marking (MDR), Distributor/Sales Portal Support, Measures according to DIN EN ISO 14971 (Risk Management), DIN EN ISO 60601, ATS/ERS Guidelines
Materials
Diagnostic Software Platform, Conformity with EU 2017/745, DIN EN ISO 60601 (Parts)
Certificates
DIN EN ISO 13485:2021-12 (QMS), EU QMS Certificate MDR (EU) 2017/745 Annex IX, MDR Transition Confirmation (EU 2023/607), DIN EN ISO 13485, MDR EU QMS Certificate (Annex IX), CE Marking, ISO 9001
Industries
Medical Technology, Pulmonary Function Diagnostics (Spirometry, PFT), Cardiopulmonary Performance Diagnostics (CPET), Hospitals
  1. 01

    Development

  2. 02

    Manufacturing in Germany

  3. 03

    CE Marking (MDR)

  4. 04

    Distribution via Distribution Partners

  5. 05

    Support & Software Updates (BLUE CHERRY)

Technology & Software

BLUE CHERRY®

Diagnostic Software Platform

Unites spirometry, PFT, and CPET diagnostic functions in one integrated platform.

MDR

Conformity with EU 2017/745

Products are CE marked in accordance with the Medical Device Regulation.

ISO 60601

DIN EN ISO 60601 (Parts)

Devices comply with the applicable parts of the standard series for medical electrical equipment as well as the ATS/ERS guidelines.

Locations

Standort Bad Kissingen

Bad Kissingen

DE

Headquarters, Development, Production

  • BLUE CHERRY® Software Platform

Products

Spirostik Blueflow
Spirostik BlueflowSpirometry · Medical Technology
PFTstik
PFTstikPulmonary Function Diagnostics (PFT) · Medical Technology
Bodystik
BodystikPulmonary Function Diagnostics (PFT) · Medical Technology
Add-on CO Diffusion
Add-on CO DiffusionPulmonary Function Diagnostics (PFT) · Medical Technology
Ergostik
ErgostikCardiopulmonary Exercise Testing (CPET) · Medical Technology
Ergostik Blueflow
Ergostik BlueflowCardiopulmonary Exercise Testing (CPET) · Medical Technology
Ambistik
AmbistikCardiopulmonary Exercise Testing (CPET) · Medical Technology
BLUE CHERRY®
BLUE CHERRY®Diagnostic Software Platform · Medical Technology

Inside the production

Ambistik – CPET
Ambistik – CPET
Geratherm Respiratory at WHX 2027 (January 25–28, 2027)
Geratherm Respiratory at WHX 2027 (January 25–28, 2027)

Industries

Medical TechnologyPulmonary Function Diagnostics (Spirometry, PFT)Cardiopulmonary Performance Diagnostics (CPET)Hospitals

Additional services

BLUE CHERRY® Diagnostic Software PlatformCertification via CE Marking (MDR)Distributor/Sales Portal SupportMeasures according to DIN EN ISO 14971 (Risk Management), DIN EN ISO 60601, ATS/ERS Guidelines

Quality & Certification

The quality management system is certified according to DIN EN ISO 13485:2021-12 (SLG Prüf- und Zertifizierungs GmbH, NB 0494), and risk management follows DIN EN ISO 14971. Devices carry the CE marking pursuant to the MDR (EU 2017/745) and the RoHS Directive.

EvidenceBad Kissingen
DIN EN ISO 13485
MDR EU QMS Certificate (Annex IX)
CE Marking
ISO 9001
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