Instruments for functional explorations and therapeutic interventionsPneumonology and respiratory physiopathology instruments
Various pneumology and respiratory physiopathology instruments
EMDN code Z121590
Manufacturers registered in Europe (EUDAMED) 113
- 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) 154
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 |
|---|---|---|---|
| Hans Rudolph, Inc. | United States | 5570 3L SYRINGE 5530 3L SYRINGE 4900 7L SYRINGE 5540 1L SYRINGE 5510 100ML SYRINGE 5550 1/2L SYRINGE | registered |
| Ventec Life Systems, Inc. | United States | VOCSN Patient Breathing Package VOCSN HomeFill® Oxygen System VOCSN Patient Air Intake Filters VOCSN Power Supply VOCSN Fan Filters | registered |
| Airsep Corp. | United States | NewLife Elite NewLife Intensity 10 NewLife Intensity VisionAire Focus FreeStyle | K150930 (2015) |
| A-M SYSTEMS, LLC | United States | Noseclip, Disposable , White, Foam Pad Disposable Blue PFT Nose Clip with Rubber Pads Disposable PFT Nose Clip with Foam Pads Disposable Blue PFT Nose Clip with Foam Pads Disposable PFT Nose Clip with Rubber Pads Disposable White PFT Nose Clip with Rubber Pads, Labeled D R Burton | registered |
| VYAIRE MEDICAL, INC. Present in Europe in other categories | United States | VMAX Avea FreeFlow™ Vyntus | K183567 (2019) |
| BELLUSCURA PLC | United States | X-PLO2R DISCOV-R | K203086 (2021) |
| Percussionaire Corp. | United States | Percussionaire | K905236 (1991) |
| Abmrc, LLC | United States | BiWaze Clear Dual Lumen Circuit - Acute BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium BiWaze Clear Dual Lumen Circuit With Mouthpiece BiWaze Cough BiWaze Clear Dual Lumen Circuit With Face Mask - Child BiWaze Clear Dual Lumen Circuit With Trach Adapter | K260604 (2026) |
| VIVE HEALTH LLC Present in Europe in other categories | United States | ViveBreathe Vive Breathe | registered |
| Mv Life LLC | United States | OxyGo OxyHome | K252407 (2026) |
| RESMED ASIA PTE. LTD. | – | Mobi External Battery Assembly Charger AC/DC with power cord Mobi Backpack Mobi Mounting Straps Mobi Shoulder Bag | registered |
| Shape Medical Systems, Inc. | United States | Shape-HF Shape Shape Vital Sign System Disposable Patient Interface with filter Shape II System Refurbished | K150888 (2016) |
| GAS CONTROL EQUIPMENT LIMITED | United Kingdom | GCE Arya | registered |
| Innovision A/S | United States | Innocor | K102047 (2011) |
| BOUND TREE MEDICAL, LLC | – | Curaplex | registered |
| Medical Graphics Corp. Present in Europe in other categories | United States | SW Ascent 2.5 Download SW ASCENT 2.4.0 DOWNLOAD Medical Graphics MGC Diagnostics | K242809 (2024) |
| NSPIRE HEALTH, INC. | United States | nSpire Health | registered |
| Vortran Medical Technology 1, Inc. Present in Europe in other categories | United States | VORTRAN-IPPB VORTRAN PercussiveNEB 2.0 VORTRAN PercussiveNEB 2.0 w/ Top Nebulizer Port VORTRAN-IPPB with Manomter VORTRAN-IPPB with Water Trap VORTRAN PercussiveNEB | K003684 (2001) |
| Invacare Corp. Present in Europe in other categories | United States | Invacare® HomeFill® Cylinder Bag Invacare® Platinum Oxygen Concentrator Invacare® Supply Line Assembly with Coiled Tubing Invacare® Perfecto2V Oxygen Concentrator | K203210 (2021) |
| Rhythm Healthcare, LLC | – | Rhythm Healthcare Rhythm Healthcare, LLC Rhythm | registered |
| Dynarex Corporation | United States | Resp-O2 PFM Nose Clips, Adult / Pediatric Oxygen Concentrator Resp-O2 10L Oxygen Concentrator Resp-O2 Oxygen Concentrator, 5L | registered |
| Medi Soft SA | Belgium | TransAir3 BodyBox | registered |
| TREYMED INC | United States | Metaphor Flow Sensor | registered |
| Vacumed | – | White w/white foam noseclip 100/bx Multicolor noseclip 50/bag Snuffer noseclip 1000/bx Multicolor noseclip 500/bag | registered |
| DALTON MEDICAL CORPORATION | United States | DALTON OXYGEN CONCENTRATOR DALTON PORTABLE OXYGEN CONCENTRATOR | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| Neotech Products LLC Present in Europe in other categories | United States | NeoSeal® | registered |
| VECTRACOR INC | United States | Nose Clips 3L Calibration Syringe | registered |
| WESTMED, INC. | United States | Inline Water Trap OxyGo Inline Water Trap, For Oxygen Delivery Composite Respiratory Kit: Nationwide Medical | K954271 (1995) |
| Weoxy Co., LTD. | – | WeOxy | registered |
| CMI HEALTH INC. | United States | SpiroLoop SpiroLink 2 Pro | registered |
| Cortex Biophysik GmbH | United States | CORTEX CPET System | K001631 (2001) |
| Draeger Medical Systems, Inc. Present in Europe in other categories | United States | Respiratory Mechanics Combined Flow/CO2 Sensor – Neonatal Respiratory Mechanics Sensor – Neonatal | registered |
| Drive Devilbiss Healthcare | United States | Roscoe Medical | registered |
| ESSEX INDUSTRIES, INC. | – | Oxygen Generator and Liquifier | registered |
| FUTUREMED AMERICA, INC. | United States | FUTUREMED | registered |
| Fisher & Paykel Healthcare, Ltd. Present in Europe in other categories | New Zealand | FISHER & PAYKEL HEALTHCARE | registered |
| Instrumentation Industries, Inc. Present in Europe in other categories | United States | NC 12585 Nose Clip SH 7-47 Nose Clip | registered |
| Molecular Products , Ltd. | United States | RUGGED OXYGEN GENERATOR (ROG) | K240561 (2024) |
| NDD Medizintechnik AG Present in Europe in other categories | Switzerland | EasyOne Pro EasyOne Pro LAB | K161534 (2017) |
| On Site Gas Systems, Inc. | United States | POGS | K092636 (2010) |
| Pulmone Advanced Medical Devices, Ltd. Present in Europe in other categories | United States | MiniBox MiniBox+ | K161295 (2016) |
| Thornhill Research Inc Present in Europe in other categories | Canada | MOVES SLC | registered |
| Allied Medical, LLC Present in Europe in other categories | United States | BF | registered |
| Cynosure, Inc. Present in Europe in other categories | United States | MEDI-FRIG | registered |
| D. E. Hokanson, Inc. Present in Europe in other categories | United States | Hokanson | K932812 (1994) |
| GERI-GENTLE CORPORATION | – | Oxygen Concentrator | registered |
| GVS FILTER TECHNOLOGY UK LTD Present in Europe in other categories | United Kingdom | Nose Clip | registered |
| HEALTHCARE LOGISTICS SYSTEMS LLC | – | Healthcare Logistics Systems | registered |
| Jones Medical Instrument Co. | United States | Satellite | K812001 (1981) |
| MERCURY ENTERPRISES, INC. | – | Nose Clip | registered |
| Medi/Nuclear Corporation, Inc. | United States | Aero/Vent Plus | registered |
| Medikro Oy Present in Europe in other categories | Finland | M9474, Medikro® Calibration Syringe, 3000 ml | registered |
| PARVOMEDICS, INCORPORATED | United States | TrueOne 2400 | K941843 (1995) |
| POLYTECHNIC RESOURCES INC | United States | Polytech Noseclip | registered |
| PROACTIVE MEDICAL PRODUCTS, LLC | – | Oxygen Concentrator | registered |
| Philips Medizin Systeme Böblingen GmbH Present in Europe in other categories | Germany | Spirometry Sensor | registered |
| RAPID OXYGEN INC | – | Rapid Oxygen R15 | registered |
| Resmed, Ltd. Present in Europe in other categories | United States | External Battery Assembly | registered |
| SPRYLYFE INC | – | ARYA | registered |
| Seoil Pacific Corp. Present in Europe in other categories | South Korea | Comfort Cough | K113549 (2013) |
| TECHNOPULM LTD | Israel | STS | registered |
| TRI-ANIM HEALTH SERVICES, INC. | – | Curaplex | registered |
| Twin Med, LLC | – | Procure | registered |
| 3B Medical, Inc. | United States | – | K200496 (2020) |
| A-Vox Systems, Inc. | United States | – | registered |
| ASIA CONNECTION CO., LTD. | Taiwan | – | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | – | registered |
| Advanced Bio Machines Pte. Ltd. | Singapore | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| Amt Corp. | United States | – | registered |
| Applied Home Healthcare Equipment | United States | – | registered |
| Asp Global, LLC | United States | – | registered |
| BESMED HEALTH BUSINESS CORP. Present in Europe in other categories | Taiwan | – | registered |
| BOEN HEALTHCARE CO., LTD. Present in Europe in other categories | China | – | registered |
| Baxter Healthcare Corp Present in Europe in other categories | United States | – | registered |
| Beijing Choice Electronic Technololgy Co., Ltd. | China | – | registered |
| Beijing Choicemmed Technology Co., Ltd. | China | – | registered |
| CEVA Logistics Netherlands BV | Netherlands | – | registered |
| Contec Medical System Co., Ltd. | China | – | K180837 (2019) |
| Coopersurgical, Inc. Present in Europe in other categories | United States | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| DYN'R Present in Europe in other categories | France | – | registered |
| Danyang Huayi Medical Supply & Equipment Co, Ltd. Present in Europe in other categories | United States | – | registered |
| Doner Industries, Inc. | United States | – | registered |
| Dongguan Yipincheng Technology Co., Ltd. | China | – | registered |
| Emg Technology Co., Ltd. | Taiwan | – | K043520 (2005) |
| Emsere, Inc | Netherlands | – | registered |
| Englert GmbH & Co. KG | Germany | – | registered |
| FINIX INDUSTRIAL CO., LTD. | Taiwan | – | registered |
| FISHER & PAYKEL HEALTHCARE NZ LTD | New Zealand | – | registered |
| FOREMOUNT ENTERPRISE CO., LTD. | Taiwan | – | registered |
| Falcon Surgical Co. (Pvt.) Ltd. Present in Europe in other categories | Pakistan | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| Flying Tooling Engineering Limited | China | – | registered |
| Foshan Kycare Medical Equipment Co., Ltd. | China | – | K251534 (2025) |
| Foxconn European Manufacturing Services s.r.o. | Czechia | – | registered |
| GALEMED CORPORATION Present in Europe in other categories | Taiwan | – | registered |
| GCE s.r.o. Present in Europe in other categories | Czechia | – | registered |
| GERUI Medical Products Co Ltd | China | – | registered |
The 100 most active manufacturers are shown, out of 154.
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.