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Emdyca

Instruments to support and monitor vital signsVital signs monitoring instrumentsGaseous exchange monitoring instruments

Gaseous exchange monitoring instruments - hardware accessories

EMDN code Z1203020480

6 manufacturers, 108 models including 106 on the market, 5 countries

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Manufacturers registered in Europe (EUDAMED) 6
  • 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
IT Dr. Gambert FDA Germany
92 others
IIa 93/42 Website info@itg-wismar.de EUDAMED record Report an error
Draeger FDA Germany I, IIb MDR Website EUDAMED@draeger.com EUDAMED record Report an error
Masimo FDA EU representative : MDSS GmbH (Germany) United States I, IIa MDR, 93/42 Website customerorders@masimo.com EUDAMED record Report an error
Radiometer FDA Denmark IIa MDR Website radiometerra_eu@radiometer.dk EUDAMED record Report an error
Vivardis France IIa MDR Website EUDAMED record Report an error
AirLife Finland No model still on the market Finland IIa 93/42 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) 71

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
MAXTEC, LLC Present in Europe in other categories United States MAXVENTURI Oxygen Sensor MAX-250 BlenderBuddy2 MAXO2+ K221734 (2023)
Analytical Industries, Inc. United States Analytical Industries Inc. K053407 (2006)
GE Healthcare Finland Oy Present in Europe in other categories Finland CARESCAPE CARESCAPE B850 CARESCAPE B450 CARESCAPE B650 CARESCAPE Software K123195 (2013)
Honeywell Healthcare Solutions GmbH Present in Europe in other categories – Oxygen Sensor MOX3 6050-0004-110 MOX2 MySign® O MOX9 registered
Edan Instruments, Inc. Present in Europe in other categories China Patient Monitor registered
Avante – Waveline Pro+ Waveline EZ-MAX Waveline Touch+ 2000 Anesthesia Replacement Oxygen Cell 1000 Anesthesia Replacement Oxygen Cell 6000 Anesthesia Replacement Oxygen Cell registered
NOXBOX LTD Present in Europe in other categories United Kingdom NOxBOXi registered
SENSORONICS INCORPORATED – Sensoronics registered
Teledyne Analytical Instrs – Teledyne Analytical Instruments Teledyne registered
CITY TECHNOLOGY LIMITED United Kingdom MOX4 MOX3 6600-1278-600 MOX9 MOX2 MOX6 K041773 (2004)
Ge Medical Systems Information Technologies Present in Europe in other categories United States B125M B155M B105M registered
ADVANCED INSTRUMENTATIONS, INC. United States ADVANCED PATIENT MONITOR registered
OHIO MEDICAL, LLC United States MiniOX registered
TREYMED INC United States Metaphor Flow Sensor registered
MEDIPINES CORPORATION United States MediPines Gas Exchange Monitor MediPines Gas Exchange Monitor Starter Kit MediPines Single Patient Use Breathing Circuit registered
SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories – Spacelabs Ultraview UltraviewSL registered
Salter Labs Present in Europe in other categories United States – K261389 (2026)
Bio-Med Devices, Inc. Present in Europe in other categories United States Bio-Med Devices, Inc. K213948 (2022)
Precision Medical, Inc. Present in Europe in other categories United States Precision Medical Inc. K173807 (2018)
Shenzhen Comen Medical Instruments Co., Ltd. Present in Europe in other categories China COMEN registered
Aei Technologies, Inc. United States S3A registered
Airgas Therapeutics, LLC Present in Europe in other categories United States Ulspira TS registered
Drive Devilbiss Healthcare United States Drive registered
Newport Medical Instruments, Inc. United States Newport Medical registered
Philips Medizin Systeme Böblingen GmbH Present in Europe in other categories Germany Spirometry Sensor registered
Resmed, Ltd. Present in Europe in other categories United States RESMED registered
Respironics Novametrix, LLC Present in Europe in other categories United States Criterion OxiCheck registered
SKANRAY TECHNOLOGIES LIMITED Present in Europe in other categories India STAR 65 registered
Vacumed – Gold Edition O2 Analyzer registered
Vyaire GmbH Present in Europe in other categories – Vital Signs™ registered
AD Supply Group Limited United Kingdom – registered
Amphenol Critical Medical Technologies, LLC United States – registered
Bio-Med Device, Inc. Present in Europe in other categories United States – K251245 (2025)
Bluepoint Medical GmbH & Co. KG Germany – registered
CBR Enterprise Limited Hong Kong SAR China – registered
CEVA Logistics Netherlands BV Netherlands – registered
Caf Medical Solutions, Inc. United States – registered
Careox, LLC United States – K213933 (2022)
Change Healthcare Canada Company Present in Europe in other categories Canada – registered
DHL Supply Chain (Netherlands) B.V. Netherlands – registered
DIGICARE BIOMEDICAL TECHNOLOGY, INC. United States – registered
DRW MEDICAL LLC United States – registered
EDAN Diagnostics, Inc. United States – registered
Flextronics International USA, Inc. United States – registered
GE HealthCare Technologies Inc. Present in Europe in other categories United States – registered
Guangdong Biolight Meditech Co., Ltd. Present in Europe in other categories China – registered
Honeywell Healthcare Solutions GmbH (formerly EnviteC) Present in Europe in other categories Germany – registered
Hosmed Inc United States – registered
INOSYSTEMS Present in Europe in other categories France – registered
Innokas Yhtyma Oy Present in Europe in other categories Finland – registered
Jaeger Medical GmbH Present in Europe in other categories Germany – registered
KB Components Finland Oy Finland – registered
KIMBALL SOLUTIONS GROUP, LLC United States – registered
Life Spark Medical, LLC United States – K250002 (2025)
Maquet Critical Care AB Present in Europe in other categories United States – registered
Mindray DS USA, Inc. United States – registered
Nihon Kohden America, Inc. Present in Europe in other categories United States – K896359 (1990)
Orantech Inc. Present in Europe in other categories China – registered
Philips Medical Systems Nederland B.V. Present in Europe in other categories Netherlands – registered
Platinum Focus Group Ltd. United Kingdom – registered
RAUMEDIC Estonia AS Estonia – registered
Salaera, LLC d.b.a Maxtec United States – registered
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Present in Europe in other categories China – registered
Spacelabs Healthcare Present in Europe in other categories United States – registered
SunMed "also trading as AirLife" United States – registered
SunMed Group Holdings, LLC dba AirLife United States – registered
TECHNICAL SERVICES FOR ELECTRONICS, INC. United States – registered
TELEFLEX INCORPORATED Present in Europe in other categories United States – registered
Teledyne Analytical Instruments United States – K024155 (2003)
VINCENT MEDICAL MANUFACTURING CO., LTD. Hong Kong SAR China – registered
Vacumed, Div. of Vacumetrics, Inc. United States – K973545 (1998)

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