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Emdyca

Instruments for functional explorations and therapeutic interventionsPneumonology and respiratory physiopathology instrumentsVarious pneumology and respiratory physiopathology instruments

Body plethysmographs

EMDN code Z12159007

8 manufacturers, 10 models including 10 on the market, 6 countries

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Manufacturers registered in Europe (EUDAMED) 8
  • On the market
  • No longer marketed
  • 93/42 Former directive, not yet certified under the MDR
  • Click a manufacturer to see its full range, a model to open its EUDAMED record.
ManufacturerCountryRegistered modelsClassContact
Cosmed FDA EU representative : Advena Limited (Malta) Italy, United States I, IIa MDR Website regulatory@cosmed.com EUDAMED record Report an error
Sensible Medical Innovations FDA EU representative : AR Experts B.V. (Netherlands) Israel IIa 93/42 Website EUDAMED record Report an error
Geratherm Respiratory Germany IIa MDR Website info@geratherm-respiratory.com EUDAMED record Report an error
Jaeger Medical FDA Germany IIa 93/42 Website EUDAMED record Report an error
medical equipment europe Germany IIa 93/42 Website info@smartpft.com EUDAMED record Report an error
PISTON Műszaki Fejlesztő, Kereskedelmi és Ügynöki Korlátolt Felelősségű Társaság Hungary IIa 93/42 Website info@pistonmedical.com EUDAMED record Report an error
SOMNOmedics FDA Germany IIa MDR Website EUDAMED record Report an error
Vitalograph FDA Ireland IIa MDR Website EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 6

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

ManufacturerCountryBrandsFDA clearance
Ganshorn Medizin Electronic GmbH Present in Europe in other categories Germany PowerCube+ Series K240706 (2024)
Medi Soft SA Belgium BodyBox registered
Cynosure, Inc. Present in Europe in other categories United States MEDI-FRIG registered
D. E. Hokanson, Inc. Present in Europe in other categories United States Hokanson K932812 (1994)
SunMed Group Holdings, LLC dba AirLife United States – registered
eResearchTechnology GmbH Present in Europe in other categories Germany – registered

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