Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signsVital signs monitoring instruments
Multi-parameter patient monitors
EMDN code Z12030202
Manufacturers registered in Europe (EUDAMED) 72
- 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.
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) 918
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 |
|---|---|---|---|
| Unimed Medical Supplies, Inc. Present in Europe in other categories | China | Unimed HU810-91 nimed Unmied | K260931 (2026) |
| APK Technology Co.,Ltd. Present in Europe in other categories | China | APK Nihon Kohden Nihon Kohden Disposable GE-Nellcor HP Kontron | K172981 (2018) |
| Salter Labs Present in Europe in other categories | United States | AirLife CapnuVue Comfort Soft Plus Gas Sampling Lines Salter ETCo2/O2 Cannula | K261389 (2026) |
| Avante | – | Waveline Pro+ Waveline EZ-MAX Waveline Touch+ Waveline VS Echo CO2 Waveline EZ+ | registered |
| SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories | – | Spacelabs Ultraview UltraviewSL Trulink SPACELABS HEALTHCARE Ultraview SL | registered |
| Covidien, LLC Present in Europe in other categories | United States | Nellcor Vital Sync Microstream Advance Microstream Nellcor OxySoft INVOS | K253030 (2026) |
| ATHENA GTX, INC. | United States | Athena GTX Device Management Suite (ADMS) Software WVSM Pro, Wireless Vital Signs Monitor Professional WVSM Wireless Vital Signs Monitor | K233354 (2024) |
| Nonin Medical, Inc. Present in Europe in other categories | United States | Nonin CO-Pilot™ Wireless Handheld Multi-Parameter System PALMSAT HANDHELD OXIMETER WristOx2 ® Pulse Oximeter HANDHELD PULSE OXIMETER FINGERTIP PULSE OXIMETER | K192900 (2020) |
| LUTECH INDUSTRIES INC Present in Europe in other categories | United States | Lutech | K150691 (2015) |
| GRAPHIC CONTROLS ACQUISITION CORP | – | Vermed VersaTrode™ PerformancePlus™ Z-Brand™ ClearScan™ SilveRest™ | registered |
| Ivy Biomedical Systems, Inc. Present in Europe in other categories | United States | Model 7600 Model 7800 Model 7600EP Model 7700 CTM-300 UPMM | K202138 (2021) |
| Mediaid, Inc. | United States | Reusable Sensor - Pedi Finger Reusable Sensor - Y Reusable Sensor - Ear Reusable Sensor - Adult Finger Reusable Sensor - Soft Adult Reusable Sensor - Soft Pedi | K071642 (2008) |
| SenTec AG Present in Europe in other categories | United States | Contact Gel Isolation Transformer 100-120V Membrane Changer Set Sentec Digital Monitor Staysite Adhesive PSG Cable A | K232516 (2024) |
| ICU MEDICAL, INC. Present in Europe in other categories | United States | BCI Portex ICU Medical | K140129 (2014) |
| Philips Medical Systems Hsg | – | ECG Electrodes Care Assist Microstream Advance Adult Oral-Nasal CO2 Filter Line Microstream Advance Pediatric Oral-Nasal CO2 Filter Line Microstream Advance Adult Nasal CO2 Filter Line IntelliSpace Perinatal | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | MEDLINE Medline Industries, Inc. PENDING | registered |
| PERMA PURE LLC | – | Perma Pure Nafion Dryer | registered |
| Tekscan, Inc. Present in Europe in other categories | United States | BPMS Evolution Strideway SR Tile Strideway HR Tile Strideway MR Tile HR Walkway VersaTek MatScan Evolution | registered |
| Norav Medical , Ltd. Present in Europe in other categories | Israel | Norav 1200 Series PC-ECG Norav 1200 Series ECG Wireless BT 12 lead resting ECG. Telemetry System. License + Software for up to 7 users 12 lead ECG for rest. | K110463 (2011) |
| Oridion Medical 1987 , Ltd. | Israel | Microstream Microstream Advance Microstream Luer Surestream Omnistream Capnostream20p | K200594 (2020) |
| MAXTEC, LLC Present in Europe in other categories | United States | Pressure Monitoring Line with Nafion Dryer (BioMed Private Label) MaxCap Reg MAXVENTURI Oxygen Sensor MAX-250 BlenderBuddy2 | K221734 (2023) |
| St Jude Medical | United States | PressureWire™ Wi-Box™ SJM™ myMerlin™ Merlin.net™ QUANTIEN™ | registered |
| Respironics, Inc. Present in Europe in other categories | United States | Trilogy Evo Trilogy Sensor Pro-Flow Trilogy Evo, O2, Japan Trilogy Evo, O2 | K972829 (1997) |
| Leonhard Lang GmbH | United States | S&W Skintact Trace1 Stable Base GE Healthcare | K092291 (2009) |
| FIAB SPA Present in Europe in other categories | Italy | F3001ECG | registered |
| BOUND TREE MEDICAL, LLC | – | Curaplex Curaplex® | registered |
| FLEXICARE MEDICAL LIMITED Present in Europe in other categories | United Kingdom | Flexicare Venticaire Lite Dual Adult Nasal Cannula with Oral Scoop Dual Adult Mask Dual Pediatric Mask Dual Adult Nasal Cannula | K201666 (2020) |
| Shenzhen Med-Link Electronics Tech Co., Ltd. Present in Europe in other categories | China | Med-link Sage PACIFIC MEDICAL | K212752 (2022) |
| TYROLMED GmbH | – | SWAROMED | registered |
| Conmed Corporation Present in Europe in other categories | United States | CLEARTRACE SOFTRACE CONMED SURETRACE POSITRACE TOTALTRACE | K083448 (2009) |
| IT Dr. Gambert GmbH Present in Europe in other categories | Germany | O2-Sensor | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | HUDSON RCI GIBECK | registered |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED PATIENT MONITOR ADVANCED VITAL SIGNS MONITOR ADVANCED CENTRAL MONITORING STATION | K132077 (2014) |
| MEDIMAX TECH INC. | – | MediMax Tech | registered |
| LifeSync Corporation | United States | AMC LifeSync | registered |
| MOBERG RESEARCH INC | United States | Component Neuromonitoring System Component Monitoring System CNS Envision | K080217 (2008) |
| Mortara Instrument, Inc. | United States | Patient Cable X12+ Patient Cable Surveyor S4 Q-Tel RMS Surveyor Patient Cable Quik-Prep | K182297 (2019) |
| 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) |
| OWENS & MINOR DISTRIBUTION, INC. | – | MediChoice | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH Kendall Uni-Patch | registered |
| Respironics Novametrix, LLC Present in Europe in other categories | United States | NM3 Monitor, Dutch NM3 Monitor, English, Refurbished NM3 Monitor, English, Rental NM3 Monitor, French NM3 Monitor, Italian NM3 Monitor, German | K103578 (2011) |
| Analytical Industries, Inc. | United States | Analytical Industries Inc. | K053407 (2006) |
| SENSORONICS INCORPORATED | – | Sensoronics Sesoronics | registered |
| CURBELL MEDICAL PRODUCTS, INC. | United States | DISP NLCR COMPAT SPO2 SNSR,NON OXMX,N25 DISP NLCR COMPAT SPO2 SNSR,OXMX,MAXN DISP NLCR COMPAT SPO2 SNSR, OXMX,SC-A REUS,PHILIPS SPO2 SNSR,9.5',LG CLAM DISP NLCR COMPAT SPO2 SNSR,OXMX,MAX-N DISP NLCR COMPAT SPO2 SNSR,OXMX,MAX-A | registered |
| AirLife Finland Oy Present in Europe in other categories | – | Vital Signs™ | registered |
| Vista Medical Ltd | – | BodiTrak | registered |
| Iradimed Corporation | United States | Iradimed | K180903 (2019) |
| Shenzhen Caremed Medical Technology Co., Ltd. Present in Europe in other categories | China | Caremed | K191279 (2019) |
| MEDICO ELECTRODES INTERNATIONAL LIMITED Present in Europe in other categories | India | Ambu WhiteSensor Ambu BlueSensor | registered |
| Airlife, Inc. | United States | AirLife™ Vital Signs™ SuperNO2VA Halyard Gas Sampling Line Vyaire | registered |
| ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | – | Safedraw™ TA-BPN VENOUS CLOSE LOOP SYSTEM Merit Medical® SAFEDRAW(TM) TA4812SD SAFEDRAW(TM) TA4812SDT | registered |
| BRAEMAR MANUFACTURING, LLC Present in Europe in other categories | United States | ER920W Cardiolabs ER9W 3GSM Brookings ER9W CDMA UNM ER9W CDMA wEvent ER9W wEvent 3GSM | K153473 (2016) |
| Honeywell Healthcare Solutions GmbH Present in Europe in other categories | – | Oxygen Sensor MOX3 6050-0004-110 MOX2 MySign® O MOX9 | registered |
| Medidata Solutions, Inc. | – | BioStamp nPoint™ BioStamp® BioStamp® nPoint | registered |
| Nikomed U.S.A., Inc. | United States | TRACE 1 NIKOTRACE Nikotab NIKOPrep NikoClips EME | K022909 (2003) |
| MERCURY ENTERPRISES, INC. | – | Manometer Neo-StatCO2<Kg End Tidal CO2 Detector Mini StatCO2 End Tidal CO2 Detector StatCO2 End Tidal CO2 Detector Oxygen Sensor | registered |
| Southmedic, Inc. | Canada | Oxy2Mask O2/EtCO2 Capnoxygen® Oxy2Pro OxyMask™ OxyMask™ II | K222511 (2023) |
| WESTMED, INC. | United States | Comfort Soft Plus CO2 Sampling Nasal Cannula CO2 Sampling Nasal Cannula Cadwell Sleepmate Comfort Soft Plus AMBU Co2 Detector CO2 Easy | K162343 (2016) |
| ANESTHESIA ASSOCIATES, INC. | United States | AincA® | registered |
| Zoe Medical, Inc. | United States | Ultraview DM3 740 SELECT DM4 Nightingale Monitoring System | K200160 (2021) |
| Bio Protech, Inc. Present in Europe in other categories | United States | Bio Protech CareFusion Baxter TELECTRODE Vyaire IMCO | K083148 (2008) |
| Ambu A/S Present in Europe in other categories | Denmark | Ambu® Disposable Pressure Manometer BlueSensor RECG Electrodes BlueSensor NECG Electrodes BlueSensor BRECG Electrodes BlueSensor MECG Electrodes BlueSensor SPECG Electrodes | K100129 (2010) |
| HEALTHCARE LOGISTICS SYSTEMS LLC | – | Virtuox Healthcare Logistics Systems Healthcare Logiix Systems HLS | registered |
| Dynarex Corporation | United States | Resp-O2 EtCO2 Nasal Sampling Cannula Resp-O2 Oxygen CO2 Pressure Line Filters Resp-O2 EtCO2 7' (2.1 m) Sampling Line, With Filter, Male/Female Connector Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0m) O2 and CO2 Tubing Resp-O2 EtCO2 7' (2.1 m) Sampling Line, Male/Male Connector Resp-O2 EtCO2 7' (2.1 m) Sampling Line, With Filter, Male/Male Connector | registered |
| ZURICH MEDICAL INC. | United States | Zurich Medical Accessory Cable Zurich Pressure Guidewire System | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson SunMark | registered |
| OSI OPTOELECTRONICS, INC. | – | Dolphin BluSat TruLink | registered |
| Shenzhen Medke Technology Co., Ltd. Present in Europe in other categories | China | Medke | K152390 (2016) |
| Vitalconnect, Inc. Present in Europe in other categories | United States | VitalPatch 2.0 VistaHub-WiFi VitalPatch® Active Biosensor VitalPatch™ 2.0 Single VistaTablet VistaPhone | K193343 (2020) |
| Bracco Injeneering SA Present in Europe in other categories | Switzerland | Injector Mounting Arm, Right EmpowerSync® Power Supply Injector Mounting Arm, Left Floor Stand EDA Clip EmpowerCTA+ Injector System | registered |
| Shenzhen Jumper Medical Equipment Co., Ltd. Present in Europe in other categories | China | JUMPER pluse oximeter Pluse oximeter | K170965 (2017) |
| 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 | K771199 (1977) |
| VENTLAB, LLC | United States | Ventlab | K093525 (2009) |
| QT Medical, Inc. Present in Europe in other categories | United States | QT ECG QHeart SENSOR | registered |
| HOPKINS UNIFORM COMPANY | – | Hopkins Medical Products® Hopkins Medical Products Handheld Pulse Oximeter | registered |
| S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD | – | OxSAT100 Sleepsense | registered |
| Jaeger Medical GmbH Present in Europe in other categories | Germany | Jaeger Vyaire | registered |
| Medical Graphics Corp. Present in Europe in other categories | United States | MGC Diagnostics Assy Meridian Series MCG Diagnostics MGC Diagnsotics | K070858 (2007) |
| NATUS NEUROLOGY INCORPORATED Present in Europe in other categories | United States | Component Neuromonitoring System CNS Envision | registered |
| Cardinal Health, Inc. Present in Europe in other categories | United States | Kendall Uni-Patch | registered |
| Boston Scientific Corp Present in Europe in other categories | United States | AVVIGO™+ AVVIGO™ Guidance System II MDU5 PLUS AVVIGO™ Guidance System MDU5 Plus™ | K170204 (2017) |
| Beta Biomed Services, Inc. | United States | B500 SERIES B400 SERIES B200 SERIES B200 B300 SERIES | K011518 (2002) |
| Finapres Medical Systems B.V. Present in Europe in other categories | Netherlands | Finapres | registered |
| HAPPY HEALTH, INC. | United States | Happy Health | K240236 (2024) |
| Bayer Medical Care Inc. Present in Europe in other categories | United States | MEDRAD® Veris™ 8600 Vital Signs Monitor | registered |
| Midmark Corp. Present in Europe in other categories | United States | Midmark Midmark Digital ECG | K253196 (2026) |
| Vivify Health, Inc. | United States | Vivifyhealth SK006 Vivifyhealth Kit 004 Vivifyhealth SK001 Vivifyhealth Kit 007 Vivifyhealth Kit 011 Vivifyhealth SK002 | K222398 (2023) |
| MULTI BIOSENSORS, INC. | United States | 2DT2 DS-03 6801 DLE-253 GS-03 DS-02 | K864690 (1987) |
| SCOTTCARE CORPORATION, THE | United States | Aermos TeleSense 3 Lead Patient Cable 30" TeleSense 3 Lead Patient Cable 40" TeleRehab Software File Manager Chroma2 7 Lead Patient Cable TeleRehab Computer | K250259 (2025) |
| BIOINTELLISENSE, INC. | United States | BioButton Charging Station BioButton At-Home Kit with Adhesives and BioButton BioDashboard BioButton At-Home Kit BioButton BioButton v3 (BBN-r, different batch, Individual Pack) | K241101 (2024) |
| Mennen Medical, Inc. | United States | VitaLogik6000 VitaLogik4500 Menntor VitaLogik4000 Enguard Ensemble | K141441 (2015) |
| TRI-ANIM HEALTH SERVICES, INC. | – | Curaplex | registered |
| ACE SURGICAL SUPPLY CO., INC. | United States | Macan ACE | registered |
| CNSystems Medizintechnik GmbH Present in Europe in other categories | Austria | ICG cable ECG cable Flying-V cuff MEDIUM Flying-V - finger cuff (small) Flying-V cuff SMALL Flying-V - finger cuff (medium) | K014063 (2002) |
| Mir Medical Intl. Research Srl Present in Europe in other categories | Italy | MIR | K081033 (2009) |
| ORICARE INC. | United States | V8800 Critical Care Ventilator | registered |
| SHENZHEN YIMI LIFE- TECHNOLOGY CO.LTD Present in Europe in other categories | China | YIMI LIFE | K240092 (2024) |
| Sotera Wireless, Inc. | United States | ViSi ViSi Mobile System Package | K180472 (2018) |
| Cas Medical Systems, Inc. | United States | FORE-SIGHT ELITE® FORE-SIGHT® FORE-SIGHT ELITE | K190270 (2019) |
| Analog Devices, Inc. | United States | SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM) SENSINEL™ CPM BASE STATION SENSINEL™ CPM WEARABLE SENSINEL™ CPM ALIGNMENT TOOL SENSINEL™ CPM REPLACEMENT ADHESIVE PAD SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack) | K260801 (2026) |
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