Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signsAnaesthesia and pulmonary ventilation support instruments
Pulmonary ventilators for hospital use
EMDN code Z12030105
Manufacturers registered in Europe (EUDAMED) 47
- 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) 85
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 |
|---|---|---|---|
| Sleepnet Corporation | United States | Veraseal 2 Full Face Non Vented Mask, Large Mojo Non Vented Full Face Mask, Medium with Headgear Mojo Non Vented Full Face Mask, Large with Headgear Veraseal 2 Full Face Non Vented Mask, Medium Mojo Non Vented Full Face Mask, Small with Headgear Mojo 2 Full Face Non Vented Mask, Large | K241943 (2024) |
| Hans Rudolph, Inc. | United States | 7500 V MASK | K030515 (2003) |
| Ventec Life Systems, Inc. | United States | VOCSN Patient Breathing Package VOCSN VOCSN High Flow Kit VOCSN Nurse Call Cable VOCSN Roll Stand VOCSN Patient Air Intake Filters | K162877 (2017) |
| Breas Medical AB Present in Europe in other categories | Sweden | Vivo 45 LS Vivo 45 LS, Vivo 65 Vivo 50, VIvo 65 Vivo 65 Vivo 50, Vivo 65, Vivo 45 LS | registered |
| CORVENT MEDICAL, INC | United States | Exhalation Valve RESPOND Ventilator RESPOND Exhalation Manifold Flow Sensors Patient Circuit Kit Green Oxygen Hose, 8ft | K241135 (2024) |
| Airon Corporation | United States | miniFlow pNeuton pNeuton Model A with 6ft Patient Circuit | K121379 (2012) |
| Bio-Med Devices, Inc. Present in Europe in other categories | United States | Bio-Med Devices, Inc. | K173973 (2018) |
| Newport Medical Instruments, Inc. | United States | Newport Newport Medical | K121891 (2012) |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | registered |
| ORICARE INC. | United States | V8800 Critical Care Ventilator | K120931 (2013) |
| Airlife, Inc. | United States | AirLife™ | registered |
| INOVYTEC MEDICAL SOLUTIONS LTD Present in Europe in other categories | Israel | Ventway Sparrow Robust Ventway Sparrow Robust Packaged Patient Circuit - Pediatric, 2.4m, 1 pcs Inlet Filter - Regular Ventway Sparrow MRI Packaged Oxygen Enrichment Kit | registered |
| Innomed Technologies Present in Europe in other categories | United States | Utopia NE Hybrid NE Hybrid HV Utopia HV | registered |
| Salter Labs Present in Europe in other categories | United States | – | registered |
| Ventis Medical Inc. | United States | Flow Sensor Reusable Primary Battery for VM-2000 Flow Sensor Cable HeroVent A.C Power Supply Emergency Ventilator Complete Package | K240807 (2024) |
| SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories | – | Spacelabs Healthcare BleaseFocus 900 Series Ventilator BleaseGenius | registered |
| HMC PREMEDICAL SPA Present in Europe in other categories | – | DIMAR | registered |
| Percussionaire Corp. | United States | Percussionaire | K905234 (1991) |
| eVent Medical, Ltd. | United States | Inspiration 7i Ventilator System EVOLUTION INSPIRATION 7i Ventilator eVolution 3e Ventilator | K130178 (2013) |
| Cosmed Srl Present in Europe in other categories | United States | COSMED | K120146 (2012) |
| ICU MEDICAL, INC. Present in Europe in other categories | United States | Pneupac | registered |
| IMTMEDICAL PTE. LTD. | Switzerland | imtmedical imtmedical pte | K183364 (2019) |
| SUNSET HEALTHCARE SOLUTIONS, INC. | United States | Breathing Circuit Ventilator Filter | registered |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED VENTILATOR | registered |
| ALPHA SOURCE INC. | – | ALPHA SOURCE BATTERY | registered |
| Datex-Ohmeda, Inc. Present in Europe in other categories | United States | CARESCAPE | K210384 (2021) |
| HSINER CO., LTD. | United States | Hsiner | K251888 (2026) |
| Instrumentation Industries, Inc. Present in Europe in other categories | United States | SG 066 Oxygen Enrichment Kit | K992670 (1999) |
| Pan-America Hyperbarics, Inc. | United States | PAHI VersalVent | K122560 (2013) |
| AD Supply Group Limited | United Kingdom | – | registered |
| Baxter Healthcare Corp Present in Europe in other categories | United States | – | registered |
| Beijing Aeomed Co., Ltd. | China | – | registered |
| Breathe Technologies | United States | – | K170037 (2017) |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CEVA Logistics Netherlands BV | Netherlands | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| DSV Contract Logistics | Mexico | – | registered |
| Dimar S.P.A. | Italy | – | K232836 (2024) |
| Draegerwerk AG & CO Kgaa | Germany | – | K253647 (2026) |
| EverX / Bindra | Australia | – | registered |
| FISHER & PAYKEL HEALTHCARE NZ LTD | New Zealand | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| GALEMED CORPORATION Present in Europe in other categories | Taiwan | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| GLOBAL TEC INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS LTDA | Brazil | – | registered |
| GPE MedTech Systeme GmbH | Germany | – | registered |
| GVS FILTER TECHNOLOGY UK LTD Present in Europe in other categories | United Kingdom | – | registered |
| HMC Group | Italy | – | registered |
| Hamiton Medical AG | Switzerland | – | K180295 (2019) |
| INT'AIR MEDICAL | France | – | registered |
| INTERNATIONAL BIOMEDICAL, LTD. Present in Europe in other categories | United States | – | registered |
| Iconic Solutions by Murcia, SL | Spain | – | K252663 (2026) |
| Inovytech Medical Solutions , Ltd. | Israel | – | K202970 (2021) |
| Inventus Power | United States | – | registered |
| Lung Assist II Inc | United States | – | registered |
| Maquet Cardiopulmonary Medikal Teknik San. Tic.Ltd. Sti. | Türkiye | – | registered |
| Maquet Critica Care AB | Sweden | – | K192604 (2020) |
| MeHow Innovative (Huizhou) Ltd. | China | – | registered |
| Mindray DS USA, Inc. | United States | – | registered |
| Mt. Olive Mfg., Co. | United States | – | registered |
| NOLATO MEDITOR AB | Sweden | – | registered |
| NextPhase Medical Devices LLC Mexico | Mexico | – | registered |
| Oconnell Regulatory Consultants, Inc. | United States | – | K232365 (2025) |
| PLEXUS CORP. | United States | – | registered |
| PPC Moulding Services Pty Ltd | Australia | – | registered |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | – | registered |
| Platinum Focus Group Ltd. | United Kingdom | – | registered |
| QUALITY TECH SERVICES, LLC | United States | – | registered |
| REACT HEALTH | United States | – | registered |
| SCIENTIFIC MOLDING CORPORATION, LTD | United States | – | registered |
| Sanmina Corporation | United States | – | registered |
| Sechrist Industries, Inc. Present in Europe in other categories | United States | – | K993167 (1999) |
| Spacelabs Healthcare Present in Europe in other categories | United States | – | K112729 (2012) |
| SunMed "also trading as AirLife" | United States | – | registered |
| SunMed Group Holdings, LLC dba AirLife | United States | – | registered |
| TD SYNNEX | United States | – | registered |
| TREYMED INC | United States | – | registered |
| Technocom Systems Sdn Bhd | Malaysia | – | registered |
| Telesair, Inc. | United States | – | K251133 (2025) |
| Thora Tech GmbH | Germany | – | registered |
| USR Electronic Systems (1987) Ltd | Israel | – | registered |
| VBM Medizintechnik GmbH Present in Europe in other categories | Germany | – | registered |
| VELCROMEX, S.A. DE C.V. | Mexico | – | registered |
| VINCENT MEDICAL MANUFACTURING CO., LTD. | Hong Kong SAR China | – | registered |
| Venture Corporation Limited | Singapore | – | registered |
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- Anaesthesia systems25 manufacturers
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- Various instruments for anaesthesia and pulmonary ventilation support14 manufacturers
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- Parent category : Anaesthesia and pulmonary ventilation support instruments112 manufacturers