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Emdyca

Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signsVital signs monitoring instruments

Vital signs monitoring instruments - hardware accessories

EMDN code Z12030280

24 manufacturers, 150 models including 147 on the market, 11 countries

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Manufacturers registered in Europe (EUDAMED) 24
  • 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
Draeger FDA EU representative : Drägerwerk AG & Co. KGaA (Germany) China, United States
60 others
I, IIb MDR, 93/42 Website eudamed.sdmi@draeger.com EUDAMED record Report an error
Philips FDA Germany
31 others
I, IIa, IIb MDR, 93/42 eudamed@philips.com EUDAMED record Report an error
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
10 others
I MDR EUDAMED record Report an error
Corscience FDA Germany I, IIb MDR Website info@corscience.com EUDAMED record Report an error
Nisshamedical FDA EU representative : NISSHA MEDICAL TECHNOLOGIES SAS (France) France, United States I MDR Website regulatory@nisshamedical.com EUDAMED record Report an error
Shenzhen Caremed Medical Technology FDA EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Sleepiz FDA EU representative : MED-RAS GmbH Regulatory Affairs Service (Germany) Switzerland IIa MDR Website info@sleepiz.com EUDAMED record Report an error
Wuxi Exanovo Medical Instrument FDA EU representative : Lotus NL B.V. (Netherlands) China I 93/42 info@wuximed.com EUDAMED record Report an error
Shenzhen SINO-K Medical Technology FDA EU representative : Prolinx GmbH (Germany) China I 93/42 EUDAMED record Report an error
smartQare Netherlands I MDR Website EUDAMED record Report an error
Teveik EU representative : MedPath GmbH (Germany) China I MDR EUDAMED record Report an error
ComfTech Italy I MDR EUDAMED record Report an error
Guangdong Biolight Meditech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR Website EUDAMED record Report an error
Hyb Slovenia I MDR EUDAMED record Report an error
Intermed FDA Italy I MDR Website EUDAMED record Report an error
Medexa Sweden I 93/42 Website info@medexa.se EUDAMED record Report an error
Progetti Italy I MDR Website info@progettimedical.com EUDAMED record Report an error
Pt Newlife Healthcare International FDA EU representative : SUNGO Europe B.V. (Netherlands) Indonesia I MDR EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands) China I MDR EUDAMED record Report an error
Shenzhen JCR Medical Technology EU representative : Lotus NL B.V. (Netherlands) China I MDR EUDAMED record Report an error
Sky Labs EU representative : Obelis s.a. (Belgium) South Korea IIa MDR Website EUDAMED record Report an error
Solaris Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR EUDAMED record Report an error
Zhengzhou Medcons Import&Export Trading EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Bio Medical Technologies EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market South Korea I 93/42 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) 7

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
Jaeger Medical GmbH Present in Europe in other categories Germany Jaeger registered
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Present in Europe in other categories China 12Pin 12-Lead Host Cable registered
Amphenol Critical Medical Technologies, LLC United States – registered
DHL Supply Chain (Netherlands) B.V. Netherlands – registered
Makar Consulting Pty Ltd Australia – registered
Maquet Critical Care AB Present in Europe in other categories United States – registered
Mindray DS USA, Inc. United States – registered

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