Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signsVital signs monitoring instruments
Gaseous exchange monitoring instruments
EMDN code Z12030204
Manufacturers registered in Europe (EUDAMED) 75
- 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.
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Other manufacturers known in the United States (FDA) 462
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.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Salter Labs Present in Europe in other categories | United States | O2 Cannula Comfort Soft Plus Salter Labs AirLife CapnuVue Gas Sampling Lines | K261389 (2026) |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | HUDSON RCI RUSCH ARROW GIBECK | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline Industries, Inc. HUDSON RCI Medline CARING PENDING | K790056 (1979) |
| FLEXICARE MEDICAL LIMITED Present in Europe in other categories | United Kingdom | Flexicare Reusable Angle Connector for CBS Bag Arm – Male to Male Reusable Angle Connector for CBS Bag Arm – Male to Female Swivel Y-Connector + CO2 Luer Lock Monitoring Port 22M-15F/22M/22M (010-623LRGE Angled Neonatal Y-Piece + CO2 Luer Lock Monitoring Port (030-622RGE) Bag Arm Connector Reusable (010-607RGE) | K140473 (2014) |
| ANESTHESIA ASSOCIATES, INC. | United States | AincA® | registered |
| Oridion Medical 1987 , Ltd. | Israel | Omnistream Microstream Microstream Advance Microstream Luer Surestream Capnostream20p | K200594 (2020) |
| SUNSET HEALTHCARE SOLUTIONS, INC. | United States | Oxygen Connector/Adapter Respiratory Accessory Nasopharyngeal Airway Oxygen Connector Connector/Adapter Tubing Connectors | registered |
| Intersurgical Incorporated Present in Europe in other categories | United States | ANTI-DROWN T-PIECE DUST CAP, 22F CONNECTOR 22M - 22F Expandable Flextube - 22mm ID, 15mm ID CONNECTOR 10M - 22F. ONLY FOR USE WITH INTERSURGICAL 10MM FLEXTUBE SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER | K122075 (2012) |
| WESTMED, INC. | United States | Adaptors/Connectors MR Patient Care LoFlo CO2 with Airway Adapters (20) MR Patient Care LoFlo CO2 with Airway Adapters (100) Adapter, 22mm X 6mm Adaptors/Conectors Adaptor | K162343 (2016) |
| Airlife, Inc. | United States | AirLife™ Airlife Vital Signs™ SuperNO2VA Halyard Gas Sampling Line | K812067 (1981) |
| BOUND TREE MEDICAL, LLC | – | Curaplex Curaplex® | registered |
| GE Healthcare Finland Oy Present in Europe in other categories | Finland | CARESCAPE CARESCAPE B850 CARESCAPE B450 CARESCAPE B650 CARESCAPE Software | K211171 (2021) |
| ICU MEDICAL, INC. Present in Europe in other categories | United States | Portex BCI | registered |
| DISPO-MED (MALAYSIA) SDN. BHD. | Malaysia | DISPO-MED Dispo-Med Nasal/Oral Dual CO2 Samp.Cannula W/O2,Adult,MLL,Tube 7ft W/Filter Dispo-Med Nasal CO2 Sampling Cannula, Paediatric, MLL, Tube 7ft Dispo-Med Nasal CO2 Sampling Cannula W/O2 Delivery,Adult, MLL, Tube 7ft W/Filter Dispo-Med Anaesthetic Gas Sampling Line, MLL, Tube 7ft Dispo-Med Nasal/Oral Dual CO2 Sampling Cannula W/O2 Delivery,Adult,MLL,Tube 10ft | K143127 (2015) |
| Dynarex Corporation | United States | Resp-O2 Nasal O2 Cannula Cushion Tip Resp-O2 Nasal O2 Cannula Super Soft Touch Resp-O2 Nasal O2 Cannula Standard Tip Resp-O2 Nasal O2 Cannula Flared Tip Resp-O2 Nasal O2 Cannulas Standard Tip Resp-O2 Nasal O2 High Flow Cannula | registered |
| VYAIRE MEDICAL, INC. Present in Europe in other categories | United States | AirLife™ Vital Signs™ AirLife AirLife™ Adult Oxygen Mask Vinyl, Under the Chin Style | K230915 (2024) |
| Analytical Industries, Inc. | United States | Analytical Industries Inc. | K053407 (2006) |
| ZOLL Medical Corporation Present in Europe in other categories | United States | PROPAQ M ECG X SERIES Cable SENSOR | registered |
| TRI-ANIM HEALTH SERVICES, INC. | – | Curaplex | registered |
| Avante | – | Waveline Pro+ Waveline EZ-MAX Waveline Touch+ Nasal CO2 Sampling Cannula With O2 Delivery Echo CO2 2000 Anesthesia Replacement Oxygen Cell | registered |
| VBM Medizintechnik GmbH Present in Europe in other categories | Germany | n.a. Right Angled Connector Sampling Line | registered |
| Southmedic, Inc. | Canada | OxyArm™ Oxy2Mask O2/EtCO2 Capnoxygen® Oxy2Pro OxyMask™ OxyMask™ II | K222511 (2023) |
| VENTLAB, LLC | United States | Ventlab | K093525 (2009) |
| BESMED HEALTH BUSINESS CORP. Present in Europe in other categories | Taiwan | NASAL CANNULA ADULT, WITH 7FT TUBE (W/ UNIVERSAL CONNECTOR ON ONE SIDE) Oxygen nasal cannula adult soft green curved nasal prongs 1 ft kink resistan NASAL CANNULA ADULT, WITH 14FT TUBE(W/ SATNDARD CONNECTOR, EAR CUSHION) Nasal cannula Adult soft clear curved nasal prongs 14 ft kink resistant tubing NASAL CANNULA CHILD, WITH 7FT TUBE (W/ UNIVERSAL CONNECTOR ON ONE SIDE) Nasal Cannula Adult,Flared Tip, Disposable W/1.2m Tube. | K143150 (2015) |
| VAPOTHERM, INC. Present in Europe in other categories | United States | Vapotherm Vapotherm Inc. | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| Respironics, Inc. Present in Europe in other categories | United States | AC611 S, AC611 HFNC, 22mm (M), JPN Trilogy Evo Trilogy Pro-Flow Trilogy Evo, O2, Japan | K770123 (1977) |
| Philips Medical Systems Hsg | – | Microstream Advance Adult Oral-Nasal CO2 Filter Line Microstream Advance Pediatric Oral-Nasal CO2 Filter Line Microstream Advance Adult Nasal CO2 Filter Line Microstream Advance Adult-Pediatric Intubated CO2 Filter Line Microstream Advance Neonatal-Infant Nasal CO2 Filter Line Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line | registered |
| Braebon Medical Corp. Present in Europe in other categories | Canada | MediByte Patient Kit PureFlow OroNasal Cannula + Filter Ultima Oral + Nasal Cannula + Filter Ultima Micro Nasal Cannula Ultima Nasal Cannula MediByte Electrode Prep Kit | registered |
| CREATE BIOTECH CO., LTD. | Taiwan | Create Biotech | registered |
| Twin Med, LLC | – | Procure | registered |
| Canadian Hospital Specialties Limited | Canada | Kraton Adult Nasal Cannula-Vinyl Neotech Ram Cannula™ Swivel Tubing Connector PEDIATRIC NASAL CANNULA | registered |
| GALEMED CORPORATION Present in Europe in other categories | Taiwan | Neb.Plus Durable Straight Connector 7.6M, 4.3F barb Babi.Plus | registered |
| ATHENA GTX, INC. | United States | WVSM Pro, Wireless Vital Signs Monitor Professional WVSM Wireless Vital Signs Monitor | registered |
| EINSTEIN ASSOCIATES LLC | – | Zacurate Innovo | registered |
| OWENS & MINOR DISTRIBUTION, INC. | – | MediChoice Halyard | registered |
| SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories | – | Trulink Spacelabs Spacelabs Healthcare Ultraview UltraviewSL | registered |
| Drive Devilbiss Healthcare | United States | ROSCOE DRIVEMEDICAL Drive Medquip Carex Roscoe Medical | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | Procedural Oxygen Mask POM EZ-Lite Pedi-POM EZ MM Pedi-POM EZ-Lite Pedi-POM EZ MF POM EZ-Lite MF | registered |
| ORICARE INC. | United States | V8800 Critical Care Ventilator | registered |
| MEDSOURCE INTERNATIONAL LLC | – | MedSource Nasal Cannula MedSource Oxygen Tubing MedSource Oxygen System MedSource Sampling Cannula | registered |
| MEDIPLUS LTD | United States | Mediplus | K131339 (2013) |
| Allied Medical, LLC Present in Europe in other categories | United States | BF | registered |
| GaleMed Xiamen Co., Ltd. Present in Europe in other categories | – | GaleMed Mindray Softip-1 Nasal Cannula, Child | registered |
| KENTRON HEALTHCARE, INC. | United States | KENTEX KENTRON CAPNOGRAPHY | registered |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | B125M CARESCAPE ONE B155M B105M | registered |
| Fisher & Paykel Healthcare, Ltd. Present in Europe in other categories | New Zealand | Fisher & Paykel Healthcare Fisher and Paykel Healthcare | registered |
| HEALTH CONNECTOR LLC | – | Acc U Rate Zacurate | registered |
| Medicomp, Inc. | United States | C02 Sampling Adapter Metered Dose Elbow Dual Swivel Elbow with Suction Port Hydrophobic Filter; 4mm M - 4mm M Metered Dose Straight Swivel Universal Dual Swivel with Straps | K880434 (1988) |
| NOXBOX LTD Present in Europe in other categories | United Kingdom | NOxBOXi | registered |
| SENSORONICS INCORPORATED | – | Sensoronics | registered |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Present in Europe in other categories | China | ORIDION CO2(Package/no accessory) 1-Slot CO2/O2 Module w/ kit (Neo) Sidestream CO2 module(FDA/FJ)II Sidestream CO2 module(FDA)II 1-Slot CO2 Module w/ kit (Neo) 115-046935-00 | registered |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED PATIENT MONITOR | registered |
| ALPHA SOURCE INC. | – | ALPHA SOURCE BATTERY | registered |
| King Systems Corporation | United States | FLEX CONNECTOR | registered |
| SUNMED, LLC Present in Europe in other categories | United States | AirLife™ Adapters/Connectors Montgomery DME Pedi Co2 Easy Co2 Easy | registered |
| Teledyne Analytical Instrs | – | Teledyne Analytical Instruments Teledyne | registered |
| TRINITY MEDICAL DEVICES INC. | – | Trinity Medical Devices | registered |
| Instrumentation Industries, Inc. Present in Europe in other categories | United States | BE 106 Adult Adapter with Vent BE 105-7 Bronchoscope Swivel SH 7-45 Bronchoscope Swivel DS 7-45 Bronchoscope Swivel BE 16-2 ReusableTee Adapter KC 1515 Adapter | K770630 (1977) |
| ENDURE INDUSTRIES | United States | Endure ENDURE INDUSTRIES | K213767 (2023) |
| Focal Point Logistics, LLC | – | ORI Airways | registered |
| APPLIED MEDICAL TECHNOLOGY, INC. Present in Europe in other categories | United States | IntelAir | registered |
| CITY TECHNOLOGY LIMITED | United Kingdom | MOX4 MOX3 6600-1278-600 MOX9 MOX2 MOX6 | K041773 (2004) |
| GURIN PRODUCTS LLC | United States | Santamedical | registered |
| Nasorcap Medical, Inc. | United States | NAZORCAP Sampler | registered |
| NextPhase Medical Devices LLC | United States | Sontek Medical | registered |
| Philips Medizin Systeme Böblingen GmbH Present in Europe in other categories | Germany | Spirometry Sensor PHILIPS Transcutaneous pO2/pCO2 Parameter Module | registered |
| TREYMED INC | United States | Metaphor Flow Sensor | registered |
| WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | – | CVS Health | registered |
| Well Lead Medical Co.,Ltd | China | Nasal Oxygen Cannula | registered |
| A-M SYSTEMS, LLC | United States | Nut and Nipple, Swivel, White (Vacuum) Nut and Nipple, Swivel, Green (Oxygen) Nut and Nipple, Swivel, Blue (Nitrous Oxide) Nut and Nipple, Swivel, B&W (Nitrogen) Nut and Nipple, Swivel, Yellow (Air) Nasal Cannula, Non-Flare, Non-Crush Resistant | registered |
| Neotech Products LLC Present in Europe in other categories | United States | Neotech RAM Cannula® | registered |
| Nox Medical ehf. | Iceland | Nox Nasal Pressure Cannula with Filter Nox RIP Belts and Cannula Kit S/M/L Nox RIP Belts and Cannula Kit M Nox Nasal Pressure Cannula with Luer-Lock Nox RIP Belts and Cannula Kit, s M Nox RIP Belts and Cannula Kit, s S/M/L | registered |
| Perimed AB | United States | TC 560 Contact Liquid TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive PF 6840-1 TC Remote Panel 1 Channel PF 6840-4 TC Remote Panel 4 Channels PF 6840-2 TC Remote Panel 2 Channels | K131253 (2013) |
| MEDIPINES CORPORATION | United States | MediPines Gas Exchange Monitor MediPines Gas Exchange Monitor Starter Kit MediPines Single Patient Use Breathing Circuit | K180902 (2019) |
| Mediox Medical Service Ltd | – | Mediox | registered |
| OHIO MEDICAL, LLC | United States | MiniOX | registered |
| TRIWALKER SERVICES LLC | – | TrackAid | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Clinical Guard | – | Clinical Guard | registered |
| EASY HEALTHCARE CORPORATION | – | Easy@Home Fingertip Pulse Oximeter Easy@Home Pulse Oximeter | registered |
| PASSY-MUIR, INC. | United States | Passy-Muir | registered |
| Resmed, Ltd. Present in Europe in other categories | United States | HumidAir ACUCARE HFNC RESMED | registered |
| VYGON Present in Europe in other categories | France | VYGON | registered |
| AMSINO INTERNATIONAL, INC. Present in Europe in other categories | United States | AMSafe® Nasal Oxygen Cannula | registered |
| Bluepoint Medical GmbH & Co. KG | Germany | GE Healthcare Airway Gas Sampling Set GE Healthcare Airway Adapter | K190824 (2019) |
| CUTTING EDGE HC BRANDS LLC | – | O2-Life™ | registered |
| Dms Laboratories | United States | HealthSmart | registered |
| FKA DISTRIBUTING CO., LLC | – | HOMEDICS | registered |
| GCMEDICA ENTERPRISE LTD.(WUXI) | China | Natus | registered |
| HSINER CO., LTD. | United States | Hsiner | registered |
| Hangzhou Formed Medical Devices Co.Ltd. | China | Nasal Cannula, Adult Nasal Cannula, Neonate Nasal Cannula, Infant Nasal Cannula, Child | registered |
| INSPIRATION HEALTHCARE LIMITED | United Kingdom | Inspire | registered |
| Innovo Medical | – | Innovo | registered |
| Jaeger Medical GmbH Present in Europe in other categories | Germany | Vyaire Jaeger | registered |
| MERCURY ENTERPRISES, INC. | – | Neo-Tee Connector Adapter Neo-StatCO2<Kg End Tidal CO2 Detector Mini StatCO2 End Tidal CO2 Detector StatCO2 End Tidal CO2 Detector | registered |
| RESPONSIVE RESPIRATORY, INC. | – | Responsive Respiratory | registered |
| Shenzhen Comen Medical Instruments Co., Ltd. Present in Europe in other categories | China | COMEN | registered |
| WAL-MART STORES, INC. | – | ReliOn Equate | registered |
| Airway Innovations, Inc. | United States | AERIS Airway - Male Luer Kit AERIS Airway - MSA Luer Kit AERIS Airway - Female Luer Kit | registered |
The 100 most active manufacturers are shown, out of 462.
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