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Emdyca

Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signsAnaesthesia and pulmonary ventilation support instruments

Pulmonary ventilators for non-hospital use

EMDN code Z12030103

11 manufacturers, 400 models including 352 on the market, 8 countries

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Manufacturers registered in Europe (EUDAMED) 11
  • 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
Respironics FDA EU representative : Respironics Deutschland GmbH & Co.KG (Germany) United States
246 others
IIa, IIb 93/42 eudamed@philips.com EUDAMED record Report an error
BNOS MediTECH EU representative : Medical Device Management Ltd (Ireland) United Kingdom (ex Northern Ireland)
120 others
IIa 93/42 Website sales@meditech.uk.com EUDAMED record Report an error
Breas FDA Sweden
2 others
IIb MDR Website EUDAMED record Report an error
Hoffrichter Germany IIa 93/42 Website info@hoffrichter.de EUDAMED record Report an error
Modül Grup Mühendislik Elektr Med İnş Eğt Ve Bilş San Tic Şti Türkiye IIb 93/42 Website EUDAMED record Report an error
Sefam France IIa MDR, 93/42 Website regulatoryaffairs@sefam-medical.com EUDAMED record Report an error
Foras Türkiye IIb 93/42 Website info@foras.com.tr EUDAMED record Report an error
Siare Italy IIb MDR Website EUDAMED record Report an error
EOVE France IIb MDR contact@eove.fr EUDAMED record Report an error
ResMed FDA EU representative : ResMed SAS (France) Australia IIa MDR EUDAMED record Report an error
Uzumcu Türkiye I 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) 25

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
Respironics California, Inc. United States PHILIPS Philips Respironics K082660 (2009)
Fisher & Paykel Healthcare, Ltd. Present in Europe in other categories New Zealand Fisher & Paykel Healthcare K233643 (2024)
Salter Labs Present in Europe in other categories United States – registered
Nihon Kohden Orangemed, Inc. Present in Europe in other categories United States Nihon Kohden K213521 (2022)
SMD Manufacturing LLC United States ReddyPort K231064 (2023)
Maquet Critical Care AB Present in Europe in other categories United States Servo-air Lite Battery module K230173 (2023)
Compal Electronics, Inc. Taiwan BreathePal Bilevel K252078 (2026)
BMC Investment Holding Limited Hong Kong SAR China – registered
BMC Medical Co., Ltd. Present in Europe in other categories China – K213169 (2022)
CEVA Logistics Netherlands BV Netherlands – registered
FISHER & PAYKEL HEALTHCARE NZ LTD New Zealand – registered
GALEMED CORPORATION Present in Europe in other categories Taiwan – registered
GVS FILTER TECHNOLOGY UK LTD Present in Europe in other categories United Kingdom – registered
Huizhou RSP Technology Co.,Ltd China – registered
Inventus Power United States – registered
MeHow Innovative (Huizhou) Ltd. China – registered
Mekics Co., Ltd. Present in Europe in other categories South Korea – K242931 (2025)
Mindray DS USA, Inc. United States – registered
Modern Medical Equipment Manufacturing Limited China – registered
PLEXUS CORP. United States – registered
Philips Medical Systems Nederland B.V. Present in Europe in other categories Netherlands – registered
REACT HEALTH United States – registered
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Present in Europe in other categories China – K252182 (2026)
SunMed "also trading as AirLife" United States – registered
W&S Plastics Pty Ltd Australia – registered

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