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Emdyca

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

Continuous positive pressure equipment

EMDN code Z12030102

37 manufacturers, 465 models including 422 on the market, 14 countries

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Manufacturers registered in Europe (EUDAMED) 37
  • 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
272 others
 IIa, IIb 93/42 eudamed@philips.com EUDAMED record Report an error
Foras Türkiye
31 others
 IIa 93/42 Website info@foras.com.tr EUDAMED record Report an error
Resvent FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
26 others
 IIa MDR, 93/42 Website info@resvent.com EUDAMED record Report an error
Yamind EU representative : Llins Service & Consulting GmbH (Germany) China
11 others
 IIa MDR, 93/42 EUDAMED record Report an error
Hoffrichter Germany
9 others
 IIa 93/42 Website info@hoffrichter.de EUDAMED record Report an error
Pulmodyne EU representative : QNET B.V. (Netherlands) United States
6 others
 IIa 93/42 EUDAMED record Report an error
Yuyue FDA EU representative : Metrax GmbH (Germany) China
4 others
 IIa MDR EUDAMED record Report an error
ResMed FDA EU representative : ResMed SAS (France) Australia
3 others
 IIa MDR EUDAMED record Report an error
Resplabs FDA EU representative : Obelis s.a. (Belgium) Mexico
2 others
 I MDR EUDAMED record Report an error
Topsonmed EU representative : Prolinx GmbH (Germany) China
2 others
 IIa MDR, 93/42 sales@topsonmed.com EUDAMED record Report an error
Dongguan Shengtu Industrial EU representative : Bauer + Herzog B.V. (Netherlands) China I MDR EUDAMED record Report an error
Guangzhou Hypnus Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR, 93/42 EUDAMED record Report an error
Medical Filtration Solutions EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) I 93/42 EUDAMED record Report an error
RespiraSource, OPC EU representative : Obelis s.a. (Belgium) Philippines I MDR Website info@resplabs.com EUDAMED record Report an error
Hunan Beyond Medical Technology FDA EU representative : MedPath GmbH (Germany) and 1 other China IIa MDR Website sale@csbeyond.com EUDAMED record Report an error
Sefam France IIa MDR, 93/42 Website regulatoryaffairs@sefam-medical.com EUDAMED record Report an error
Beijing Rongrui-Century Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa 93/42 Website EUDAMED record Report an error
BMC Medical FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Phoenix Medical Systems EU representative : Obelis s.a. (Belgium) India IIb 93/42 Website EUDAMED record Report an error
Wellell FDA EU representative : Wellell Iberia S.L. (Spain) Taiwan IIa 93/42 marketing@wellell.com EUDAMED record Report an error
B L Lifesciences EU representative : Obelis s.a. (Belgium) India IIb 93/42 Website regulatory@bllifesciences.com EUDAMED record Report an error
Draeger FDA Germany IIb MDR Website EUDAMED@draeger.com EUDAMED record Report an error
Hadleighhealth FDA EU representative : Emergo Europe B.V. (Netherlands) United States IIb 93/42 Website EUDAMED record Report an error
Heyer Care EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Heyer Medical Germany IIa MDR Website EUDAMED record Report an error
Hmc Premedical FDA Italy IIa MDR Website info@hmcgroup.it EUDAMED record Report an error
Mekics FDA EU representative : Obelis s.a. (Belgium) South Korea IIb 93/42 Website EUDAMED record Report an error
Ningbo David Medical Device FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb MDR Website EUDAMED record Report an error
Northern Meditec EU representative : Umedwings Netherlands B.V. (Netherlands) China IIa MDR Website EUDAMED record Report an error
Sentechfrance France I MDR Website EUDAMED record Report an error
Shenyang RMS Medical Tech EU representative : MedPath GmbH (Germany) China IIa MDR EUDAMED record Report an error
ShenZhen Bi-rich Medical Devices FDA EU representative : SUNGO Europe B.V. (Netherlands) China IIa MDR EUDAMED record Report an error
Sleepinnov France IIa 93/42 Website contact@sleepinnov.com EUDAMED record Report an error
Sxt - Sistemi Per Telemedicina Italy IIa MDR Website info@sxt-telemed.it EUDAMED record Report an error
Xiaoniu Health EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Breas FDA No model still on the market Sweden IIa 93/42 Website EUDAMED record Report an error
Intersurgical FDA No model still on the market Italy IIb MDR 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) 46

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
MERCURY ENTERPRISES, INC. – Flow-Safe Disposable CPAP System Flow-Safe II Disposable CPAP System Flow-Safe II EZ Disposable CPAP System Flow-Safe II+ BiLevel Disposable CPAP System PEEP Valve Flow-Safe II Low FiO2 Elbow registered
BOUND TREE MEDICAL, LLC – Curaplex Curaplex® registered
Respironics Novametrix, LLC Present in Europe in other categories United States Whisperflow CPAP Valve WhisperPak, 7.5cmH2O - 22mm CPAP, Case 10 WhisperPak, M520 V5 H113 T2m, Case 10 WhisperPak, 7.5cmH2O CPAP Bari U Hosp 10 WhisperPak, M691 V10 T2m C500, Case 10 WhisperPak, 10cmH2O - 22mm CPAP, Case 10 registered
ANESTHESIA ASSOCIATES, INC. United States AincA AincA® registered
Covidien, LLC Present in Europe in other categories United States Shiley Mallinckrodt registered
FLEXICARE MEDICAL LIMITED Present in Europe in other categories United Kingdom Neoforce Infant Resuscitation Kit. T-Piece Circuit Infant Resuscitation Kit T-Piece Circuit Infant Resuscitator T-Piece Catheter Access Adapter Infant Resuscitation Kit T-Piece Circuit 1.8m (70") with Anatomical Mask Size 1 Infant Resuscitator T-Piece Circuit with Adjustable PEEP registered
GALEMED CORPORATION Present in Europe in other categories Taiwan – K133957 (2014)
B.L.S. Systems Limited Canada Rescuer II Compact CPAP System Rescuer Emergency CPAP System Rescuer Emergency CPAP with Nebulizer Kit Rescuer II Compact CPAP System with Medium Deluxe CPAP Mask and Nebulizer Kit Disposable PEEP valve with converter Rescuer Emergency CPAP with Medium CPAP Mask registered
BESMED HEALTH BUSINESS CORP. Present in Europe in other categories Taiwan PEEP VALVE 20cmH2O Non-Rebreathing Valve with Manometer Port (L Type) PEEP VALVE 12.5cmH2O PEEP VALVE 10cmH2O DISPOSABLE PEEP VALVE 5-20cmH2O, BLUE, ID:30mm PEEP VALVE 2.5cmH2O K160112 (2016)
O-Two Medical Technologies Inc Present in Europe in other categories Canada o_two CPAP CARevent CPAP K112546 (2011)
VYGON Present in Europe in other categories France VYGON K013884 (2003)
ICU MEDICAL, INC. Present in Europe in other categories United States Pneupac Portex registered
Ambu A/S Present in Europe in other categories Denmark Disposable PEEP 20 valve Reusable PEEP 10 valve Reusable PEEP 20 valve K923976 (1993)
Airlife, Inc. United States AirLife™ registered
Engineered Medical Systems United States AccuPAP APV- Adjustable PEEP Valve A-PEP O2-MAX K983920 (1999)
VENTLAB, LLC United States Ventlab registered
SUNMED, LLC Present in Europe in other categories United States WaterPAP™ Sunmed AirLife™ registered
WESTMED, INC. United States WaterPAP Pole Clamp Bracket with Tube Guide WaterPAP Pro WaterPAP Neo-Vent Infant T-Piece Resuscitation Circuit, Gas Supply K955047 (1996)
AIRWAYS DEVELOPMENT COMPANY LLC United States WaterPAP Starter Kit WaterPAP PRO WaterPAP WaterPAP PRO Starter Kit K110713 (2011)
MDL Solutions Incorporated United States Emergent Respiratory registered
Instrumentation Industries, Inc. Present in Europe in other categories United States BE 142-A BE 142 BE 30-142 K963347 (1997)
B&B Medical Technologies, Inc. United States B&B Bubbler registered
GaleMed Xiamen Co., Ltd. Present in Europe in other categories – GaleMed registered
Laerdal Medical AS Present in Europe in other categories Norway The BAG PEEP Valve 5-20 cmH2O The BAG PEEP Valve 2-10 cmH2O registered
MEDLINE INDUSTRIES, INC. Present in Europe in other categories United States Medline Industries, Inc. registered
TELEFLEX INCORPORATED Present in Europe in other categories United States RUSCH registered
Allied Medical, LLC Present in Europe in other categories United States EM registered
KENTRON HEALTHCARE, INC. United States KENOREX registered
ASIA CONNECTION CO., LTD. Taiwan – registered
Airon Corporation United States – registered
Amphenol Critical Medical Technologies, LLC United States – registered
BEMS Holdings, LLC United States – registered
CBR Enterprise Limited Hong Kong SAR China – registered
CEVA Logistics Netherlands BV Netherlands – registered
Cheen Houng Ent. Co. , Ltd. Taiwan – K981415 (1998)
Draegerwerk AG & CO Kgaa Germany – registered
FOREMOUNT ENTERPRISE CO., LTD. Taiwan – registered
Flying Tooling Engineering Limited China – registered
HSINER CO., LTD. United States – registered
Medtronic, Inc. Present in Europe in other categories United States – registered
Mercury Medical Enterprises, LLC Present in Europe in other categories United States – registered
POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. China – registered
Philips Medical Systems Nederland B.V. Present in Europe in other categories Netherlands – registered
Plaxtron Industrial (M) Sdn. Bhd. Taiwan – registered
Sanicure BV Netherlands – registered
SunMed Group Holdings, LLC dba AirLife United States – registered

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