Instruments for functional explorations and therapeutic interventionsNeurology and neurosurgery instrumentsPolysomnography instruments
Polysomnography instruments - consumables
EMDN code Z12100585
Manufacturers registered in Europe (EUDAMED) 11
- 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) 98
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 |
|---|---|---|---|
| Respironics, Inc. Present in Europe in other categories | United States | Sensor Pro-Tech CT2 Effort Sensor Airflow Sensor Thermistor NasalOral, Alice PDx, 220 | K982550 (1998) |
| GE Healthcare Finland Oy Present in Europe in other categories | Finland | CARESCAPE PORTRAIT AAB01 CARESCAPE B850 CARESCAPE B450 PORTRAIT HSWXB | registered |
| CADWELL INDUSTRIES, INC. Present in Europe in other categories | United States | Cadwell | registered |
| Conmed Corporation Present in Europe in other categories | United States | CONMED | registered |
| Edan Instruments, Inc. Present in Europe in other categories | China | Patient Monitor Telemetry Transmitter | registered |
| SenTec AG Present in Europe in other categories | United States | 1ST273-100 LuMon™ Belt Size 22 1ST278-100 LuMon™ Belt Size 47 1ST274-100 LuMon™ Belt Size 26 103583 LuMon™ Contact Gel Kit 1ST282-100 LuMon™ Belt Size 80 1ST283-100 LuMon™ Belt Size 92 | registered |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | Portrait CSSXB Portrait CVAXB B125M CARESCAPE ONE B155M | K962781 (1997) |
| Sibel Health Inc. Present in Europe in other categories | United States | ANNE Bedside Wireless Charger Sibel Spacelabs Trek Chest Patch 7-Day ANNE Chest Adhesive Shelf Box ANNE Chest Sensor Kit Sibel Spacelabs Trek Chest Patch Adhesive Sibel Spacelabs Trek Charger | registered |
| 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) | registered |
| HAPPY HEALTH, INC. | United States | Happy Health | registered |
| Earlysense, Ltd. | Israel | EarlySense® Bedside Unit EarlySense® Chair Sensor EarlySense® Contact-Free Sensor EarlySense® BEX Sensor EarlySense® InSight™ Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® | K171836 (2018) |
| Ambu A/S Present in Europe in other categories | Denmark | SleepmateCannuTherm Thermistor - Alice 3 SleepmateCannuTherm Thermocouple - 90 cm SleepmateThermistor AirFlow - 90 cm SleepmateResp. Effort System, Double Buckle - Cadwell Airflow Thermistor 78 inSleepmate SleepmateOne Channel Thermistor, Infant (Cable, Interface & 10 sensors | registered |
| Masimo Corporation Present in Europe in other categories | United States | RD rainbow SET RAM RAS-45 Radius VSM rainbow SET | K173976 (2018) |
| Huxley Medical | United States | SansaTM | registered |
| Respiratory Motion, Inc. | United States | ExSpiron 1Xi ExSpiron | registered |
| Schiller AG Present in Europe in other categories | Switzerland | Diagnostic Station DS20 | registered |
| BIOBEAT TECHNOLOGIES LTD Present in Europe in other categories | Israel | BB-613 H@H kit BB-613P Chest-Monitor 40-Unit Multipack BB-613W Wrist-Monitor | registered |
| Contec Medical Systems Co., Ltd. Present in Europe in other categories | China | CONTEC | registered |
| LifeSync Corporation | United States | MULTIFLOW ULTRAFLOW | registered |
| M3DICINE PTY LTD | Australia | Stethee Pro Mobile Android Application Stethee Pro Mobile iOS Application Stethee Pro Central Web Application | registered |
| Senzime AB (Publ.) Present in Europe in other categories | – | ExSpiron Pediatric PadSets ExSpiron PadSets ExSpiron 2Xi | registered |
| CURRENT HEALTH LIMITED Present in Europe in other categories | United Kingdom | Current Health Wearable Monnitoring System | registered |
| Corsano Health B.V. Present in Europe in other categories | Netherlands | Corsano CardioWatch 287-2 System | registered |
| HHS SYSTEMS, INC. | United States | HindexRV | registered |
| Hill-Rom, Inc. Present in Europe in other categories | United States | Heart and Respiration Rate Monitoring System powered by EarlySense | K202018 (2021) |
| ICU MEDICAL, INC. Present in Europe in other categories | United States | BCI | registered |
| NETEERA TECHNOLOGIES LTD Present in Europe in other categories | Israel | Neteera 130H/131H Vital Sign Monitoring Sensor Neteera 130H-Plus | registered |
| Philips Medizin Systeme Böblingen GmbH Present in Europe in other categories | Germany | IntelliVue CL Respiration Pod Spirometry Sensor | registered |
| CONVEXITY SCIENTIFIC LLC | – | Spire Health Remote Patient Monitoring System | registered |
| Circadiance, LLC | United States | Synergy E | registered |
| Covidien, LLC Present in Europe in other categories | United States | Nellcor | K111933 (2012) |
| Heroic Faith International Ltd. | Taiwan | Heroic Faith | K242798 (2025) |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Present in Europe in other categories | China | RM Module(package/no accessory) | registered |
| Sleepiz AG Present in Europe in other categories | Switzerland | Sleepiz One+ | registered |
| Xandar Kardian Korea Inc. | – | Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E) | registered |
| ACTIGRAPH L.L.C. | United States | – | registered |
| AD Supply Group Limited | United Kingdom | – | registered |
| ASIA CONNECTION CO., LTD. | Taiwan | – | registered |
| Aidar Health, Inc | United States | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| Baxter Healthcare Corp Present in Europe in other categories | United States | – | registered |
| Baxter Healthcare Corproration | United States | – | K223246 (2022) |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CEVA Logistics Netherlands BV | Netherlands | – | registered |
| Caf Medical Solutions, Inc. | United States | – | registered |
| Change Healthcare Canada Company Present in Europe in other categories | Canada | – | registered |
| Circadia Technologies, Ltd. | United Kingdom | – | K200445 (2020) |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| DONGGUAN SMART MANUFACTURING PARTNER ELECTRONIC COMPANY LIMI | China | – | registered |
| Draeger Medical Systems, Inc. Present in Europe in other categories | United States | – | registered |
| Dynamic EMS Ltd | United Kingdom | – | registered |
| EDAN Diagnostics, Inc. | United States | – | registered |
| EMPATICA SRL Present in Europe in other categories | Italy | – | registered |
| EVER PPE INC | United States | – | registered |
| Edwards Lifesciences, LLC Present in Europe in other categories | United States | – | K251326 (2026) |
| Engineered Medical Systems | United States | – | registered |
| Faceheart Corp. | Cayman Islands | – | K243966 (2025) |
| Fukuda Denshi USA, Inc. Present in Europe in other categories | United States | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| Gereonics, Inc. | United States | – | K062883 (2007) |
| Guangdong Biolight Meditech Co., Ltd. Present in Europe in other categories | China | – | registered |
| HI-P ELECTRONICS (MALAYSIA) SDN. BHD. | Malaysia | – | registered |
| Infinium Medical | United States | – | registered |
| Intelligent Dots, LLC | United States | – | K253274 (2026) |
| KIMBALL SOLUTIONS GROUP, LLC | United States | – | registered |
| Kaynes Technology India Limited | India | – | registered |
| Key-Tech Scotland LTD | United Kingdom | – | registered |
| L-Tek d.o.o. | Slovenia | – | registered |
| Leonhard Lang GmbH | United States | – | registered |
| Linshom Management, LLC | United States | – | K190734 (2020) |
| Linshom Medical, Inc. | United States | – | K250093 (2025) |
| MILLSTONE MEDICAL OUTSOURCING LLC. | United States | – | registered |
| Makani Science, Inc. | United States | – | K233953 (2025) |
| Maquet Critical Care AB Present in Europe in other categories | United States | – | registered |
| Mt. Olive Mfg., Co. | United States | – | registered |
| Natus Medical Incorporated Present in Europe in other categories | United States | – | registered |
| Neurovirtual USA, Inc. Present in Europe in other categories | United States | – | registered |
| NextPhase Medical Devices LLC | United States | – | registered |
| Nortech Systems, Inc. | United States | – | registered |
| Pepin Mfg., Inc. | United States | – | registered |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | – | K242001 (2025) |
| Pmd Solutions | Ireland | – | K220111 (2022) |
| Pneumacare Limited | United Kingdom | – | K151940 (2016) |
| Respiree Pte, Ltd. Present in Europe in other categories | Singapore | – | K250934 (2025) |
| Rtm Vital Signs, LLC | United States | – | K243183 (2025) |
| Ryder Electronics (Shenzhen) Ltd. | China | – | registered |
| Senzime AB Present in Europe in other categories | Sweden | – | registered |
| Shenzhen Fiber Medical Technology Co. , Ltd. | China | – | K190775 (2019) |
| Sound Life Sciences, Inc. | United States | – | K211387 (2021) |
| 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 |
| Turtle Shell Technologies Private Limited Present in Europe in other categories | India | – | K221555 (2022) |
| VELCROMEX, S.A. DE C.V. | Mexico | – | registered |
| Wesper, Inc. | United States | – | registered |
| Worldwide Supplies Limited | Hong Kong SAR China | – | registered |
| Wuhan Strong Electronics | China | – | registered |
| Xandar Kardian, Inc. | South Korea | – | registered |
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