Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signsAnaesthesia and pulmonary ventilation support instruments
Portable pulmonary ventilators
EMDN code Z12030104
Manufacturers registered in Europe (EUDAMED) 25
- 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) 38
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 |
|---|---|---|---|
| MERCURY ENTERPRISES, INC. | – | Neo-Tee T-Piece Resuscitator Neo-Tee T-Piece Resuscitator Circuit Resusa-Tee T-Piece Resuscitator Neo-Tee Tubing Kit | registered |
| ICU MEDICAL, INC. Present in Europe in other categories | United States | Pneupac BCI Portex | registered |
| ANESTHESIA ASSOCIATES, INC. | United States | AincA AincA® | registered |
| Fisher & Paykel Healthcare, Ltd. Present in Europe in other categories | New Zealand | FISHER & PAYKEL HEALTHCARE | registered |
| BOUND TREE MEDICAL, LLC | – | Curaplex | registered |
| ATOM MEDICAL CORPORATION Present in Europe in other categories | United States | Resusci Flow Rail mounting type Resusci Flow w/Blender/Rail mounting type Suction Canister, 500mL For S401D Resuscitation Unit P type Resuscitation Unit E type Patient Circuit | K102542 (2011) |
| VENTLAB, LLC | United States | Ventlab | K173373 (2018) |
| Airon Corporation | United States | MACS | K080692 (2008) |
| Automedx, Inc. | United States | SAVe II+ | K131877 (2014) |
| Instrumentation Industries, Inc. Present in Europe in other categories | United States | Manual Jet Ventilator | K991785 (1999) |
| Safeguard US Operating, LLC | United States | SAVe II+ Simplified Automated Ventilator SAVeII+ Starter Bundle, 3-Patient – Basic SAVeII+ Starter Bundle, 10-Patient – Basic | registered |
| EMERGENCY MEDICAL PRODUCTS, INC. | – | Emergency Medical Products | registered |
| INTERNATIONAL BIOMEDICAL, LTD. Present in Europe in other categories | United States | LifeBorne Puffin Infant Resuscitator Puffin Lite Infant Resuscitator | K182956 (2019) |
| MADA MEDICAL PRODUCTS, INC | United States | MADA MEDICAL PRODUCTS, INC. | registered |
| Datex-Ohmeda, Inc. Present in Europe in other categories | United States | Giraffe Stand-alone Infant Resuscitation System | registered |
| INTERNATIONAL EMERGENCY SERVICES SOCIEDAD LIMITADA. | – | Ventrain® | registered |
| MAGNAMED TECNOLOGIA MEDICA SA | Brazil | OXYMAG | K221634 (2023) |
| MDL Solutions Incorporated | United States | Emergent Respiratory | registered |
| Ventinova Medical B.V. | – | Ventrain | registered |
| AD Supply Group Limited | United Kingdom | – | registered |
| AXCESOR LLC | United States | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| BEMS Holdings, LLC | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| Cpr Medical Devices, Inc. | United States | – | K944349 (1995) |
| Draegerwerk AG & CO Kgaa | Germany | – | K242769 (2025) |
| FISHER & PAYKEL HEALTHCARE NZ LTD | New Zealand | – | registered |
| GALEMED CORPORATION Present in Europe in other categories | Taiwan | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| International Emergency Services S.L | Spain | – | registered |
| LifeSafe Services | United States | – | registered |
| Linamar Innovation Hub | Canada | – | registered |
| Mercury Medical Enterprises, LLC Present in Europe in other categories | United States | – | registered |
| Plastiflex Healthcare Division of Plastiflex Group NV | Belgium | – | registered |
| Plaxtron Industrial (M) Sdn. Bhd. | Taiwan | – | registered |
| Sonoco Plastics b.v. | Netherlands | – | registered |
| SunMed Group Holdings, LLC dba AirLife | United States | – | registered |
| Thornhill Medical | Canada | – | registered |
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Related categories
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- Continuous positive pressure equipment37 manufacturers
- Anaesthesia systems25 manufacturers
- Various instruments for anaesthesia and pulmonary ventilation support14 manufacturers
- Pulmonary ventilators for non-hospital use11 manufacturers
- Parent category : Anaesthesia and pulmonary ventilation support instruments112 manufacturers