Instruments for functional explorations and therapeutic interventionsPneumonology and respiratory physiopathology instruments
Spirometry instruments
EMDN code Z121501
Manufacturers registered in Europe (EUDAMED) 45
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 248
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 |
|---|---|---|---|
| Vitalograph , Ltd. Present in Europe in other categories | United States | VitaloROV+ VitaloROV 9100 VITALOGRAPH VitaloLAB+ Micro Model 4000 Alpha | K221030 (2022) |
| POLYTECHNIC RESOURCES INC | United States | Polytech Filter Polytech Mouthpiece | K042758 (2005) |
| A-M SYSTEMS, LLC | United States | Mouthpiece, 0.86" OD, 2.00" L for Old Peak Flow Meter Mouthpiece, Disposable, 1-1/16" O.D., 2.625" L Mouthpiece, Disposable, 1.02" ID, 2.55" Length Disposable Thermoplastic Mouthpiece Mouthpiece, Disposable, One-Way Valve Mouthpiece, Disposable, 1.01 OD, 2.625" L | registered |
| TRI-ANIM HEALTH SERVICES, INC. | – | Curaplex | registered |
| Medical Graphics Corp. Present in Europe in other categories | United States | SW Ascent 2.5 Download SW ASCENT 2.4.0 DOWNLOAD MGC Diagnostics MCG Diagnostics MGC Diagnotics | K242809 (2024) |
| Sdi Diagnostics, Inc. | United States | mouthpiece Air Tube Safe T Check Safe T Check Astraguard Astra Spirometer | K150515 (2016) |
| Vacumed | – | Disposable Mouthpiece 35mm OD Disposable Mouthpiece 26mm OD Disposable Mouthpiece 22mm OD Disposable Mouthpiece 29mm OD Disposable Mouthpiece 30mm OD Disposable Mouthpiece 19mm OD | registered |
| Welch Allyn, Inc. Present in Europe in other categories | United States | Welch Allyn, Inc. | K191013 (2019) |
| VYAIRE MEDICAL, INC. Present in Europe in other categories | United States | VMAX Avea FreeFlow™ AirLife™ | registered |
| Clement Clarke, Inc. | United Kingdom | Clement Clarke International Mini Wright In-Check Airzone Mini-Wright Able | K053156 (2006) |
| Intersurgical Incorporated Present in Europe in other categories | United States | EasySpeak NIV ANGLED MOUTHPIECE WITH NOTCH 22M/15F T-MOUTHPIECE FOR CIRRUS NEBULISER MOUTHPIECE, 22M NEBULISER ANGLED MOUTHPIECE 22M-22M NIV ANGLED MOUTHPIECE WITH NOTCH 15M | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | HUDSON RCI Medline | registered |
| NSPIRE HEALTH, INC. | United States | nSpire Health Hudson RCI | registered |
| Acme United Corporation | United States | First Aid Only | registered |
| Utah Medical Products, Inc. Present in Europe in other categories | United States | DISPIRO | K791177 (1979) |
| ANESTHESIA ASSOCIATES, INC. | United States | AincA® | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| ALLIANCE TECH MEDICAL INC | United States | All Flow Peds Disp Mthpc. InFloCone-V InFloCone All Flow Resp. Disp. Mthpc. All Flow Valved Ex.Mthpc. All Flow Mthpc. Adapter | registered |
| Innovision A/S | United States | Innocor | K083879 (2009) |
| Salter Labs Present in Europe in other categories | United States | – | K863656 (1986) |
| CREATE BIOTECH CO., LTD. | Taiwan | Create Biotech | registered |
| Midmark Corp. Present in Europe in other categories | United States | Disposable Spirometer Mouthpieces Midmark Digital Spirometer Midmark Digital Spirometer w/Calibration Syringe Midmark IQspiro® Digital Spirometer Midmark IQspiro Digital Spirometer Midmark IQspiro® Digital Spirometer with Calibration Syringe | 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) |
| Respironics, Inc. Present in Europe in other categories | United States | Sensor Pro-Tech WIRE SET Sensosr | registered |
| Bionet Co., Ltd. Present in Europe in other categories | South Korea | Cardio Q50, Cardio Q70 Spiro Handle Cardio7 | K130322 (2013) |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| Dynarex Corporation | United States | Resp-O2 Durable Peak Flow Mouthpiece with One-Way Valve,Adult Resp-O2 Cardboard Peak Flow Mouthpiece, Disposable, Adult Resp-O2 Cardboard Peak Flow Mouthpiece, Disposable, Pediatric Resp-O2 Peak Flow Meter Full Range 50-800 L/min Resp-O2 Peak Flow Meter Low Range 50-300 L/min | registered |
| Monaghan Medical Corp. | United States | TruZone® TruPeak® Strive® | K123945 (2013) |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | HUDSON RCI | registered |
| FEELLIFE HEALTH INC. | China | Pressure gas blowpipe Mouthpiece Disposable Mouthpiece Spirometer | K222443 (2023) |
| Morgan Scientific, Inc. | United States | ComPAS2 ComPAS | K213872 (2022) |
| SAFEY MEDICAL DEVICES PRIVATE LIMITED | – | Safey Pocket Spirometer NxGen Pocket Spirometer Safey Peak Flow Meter NxGen Peak Flow Meter | registered |
| Airlife, Inc. | United States | AirLife™ | K821128 (1982) |
| Allied Medical, LLC Present in Europe in other categories | United States | BF | registered |
| Covidien, LLC Present in Europe in other categories | United States | Puritan Bennett Nellcor | registered |
| D R BURTON HEALTHCARE, LLC | United States | T-PIECE ADAPTER | registered |
| Drägerwerk AG & Co. KGaA Present in Europe in other categories | Germany | Infinity ID Flow Sensor SpiroLife Spirolog Flow Sensor | registered |
| FUTUREMED AMERICA, INC. | United States | FUTUREMED | K973456 (1998) |
| Medi/Nuclear Corporation, Inc. | United States | SAFE-T-SHIELD Mouthpiece Insta/Vent - Safe-T-Shield Mouthpiece | K865093 (1987) |
| PULMONX CORPORATION | United States | Pulmonx Chartis Tablet Console Chartis Console | K180011 (2018) |
| Shenzhen Konmed Technology Co., Ltd. Present in Europe in other categories | China | Konmed | registered |
| ANDESFIT LIMITED | – | Andnesfit Health Andesfit | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Symmetry McKesson Symmetry Denhardt | registered |
| Benson Medical Instruments Co. | United States | – | K123896 (2013) |
| CMI HEALTH INC. | United States | SpiroLoop SpiroLink 2 Pro | registered |
| Corsano Health B.V. Present in Europe in other categories | Netherlands | Corsano CardioWatch 287-2 System | registered |
| FORA CARE INC. Present in Europe in other categories | Taiwan | FORA | registered |
| GVS FILTER TECHNOLOGY UK LTD Present in Europe in other categories | United Kingdom | Spiroguard Spiroguard Noseclip-Cheek holder | registered |
| HCMED INNOVATIONS CO., LTD. | – | Aerogen®Go Pulmogine | registered |
| Koko, LLC | – | KoKo, LLC | registered |
| MAICO Diagnostics GmbH Present in Europe in other categories | United States | Benson | registered |
| Monitored Therapeutics, Inc. | United States | Turbine Assembly, Bagged for GoSpiro Spirometer GoSpiro | K202837 (2020) |
| Pulmone Advanced Medical Devices, Ltd. Present in Europe in other categories | United States | MiniBox MiniBox+ | K141793 (2015) |
| RESPIRATORY DELIVERY SYSTEMS INC | United States | Microchamber Microspacer | registered |
| VECTRACOR INC | United States | Plastic Mouthpieces (100) Orbit Spirometer | registered |
| WALGREEN CO. | – | Walgreens | registered |
| Caring Mill | – | caring mill | registered |
| Chongqing Moffy Innovation Technology Co., Ltd. | China | sonmol | K241338 (2024) |
| Cortex Biophysik GmbH | United States | CORTEX CPET System | K993641 (2000) |
| Draeger Medical Systems, Inc. Present in Europe in other categories | United States | Respiratory Mechanics Flow Sensor – Adult/Pediatric | registered |
| EON MEDITECH PRIVATE LIMITED | – | OSSEOUS-SnorOFF | registered |
| Engineered Medical Systems | United States | Pulmonary Function Filter | K013123 (2002) |
| GENIA MEDICAL, INC. | United States | AsthmaMD | registered |
| Guangzhou Red Elephant Medical Technology Co.,Ltd | – | SpiroLink | registered |
| HOME AIDE DIAGNOSTICS, INC. | – | Pure Comfort Adult Inhaler Spacer Chamber | registered |
| Honeywell Healthcare Solutions GmbH Present in Europe in other categories | – | Flow sensor | registered |
| Instrumentation Industries, Inc. Present in Europe in other categories | United States | BE 120-22D Mouthpiece Adapter | registered |
| KNOX MEDICAL DIAGNOSTICS INC. | United States | Aluna | K232588 (2024) |
| Keybo Technologies Ltd | – | Keybo Technologies Ltd. CPR Face Shield | registered |
| MERCURY ENTERPRISES, INC. | – | Disp-o-seal | registered |
| MESI d.o.o. | Slovenia | MESI mTABLET SPIRO | K251777 (2026) |
| MICROBASE TECHNOLOGY CORP. | – | POCKET AIR | registered |
| Medi Soft SA | Belgium | SpiroAir | registered |
| Ningbo Hanyue Medical Technology Co., Ltd. | China | Hanwell | registered |
| Omron Healthcare, Inc. Present in Europe in other categories | United States | Omron Peak A-I-R Peak Flow Meter | registered |
| PARKER-HANNIFIN CORPORATION | United States | MOUTHPIECE (NON CE) | registered |
| PMD HEALTHCARE, INC. | United States | Spiro PD | K103575 (2011) |
| Pall International Sàrl Present in Europe in other categories | United States | Pall® Pro-Tec Filter for Pulmonary Function Testing | registered |
| RESTECH SRL Present in Europe in other categories | Italy | Resmon PRO FULL | registered |
| SIMPLE DIAGNOSTICS INC | United States | Clever Choice Peak Flow Meter | registered |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Present in Europe in other categories | China | Respiratory Mech mod,w/accssry | registered |
| TECHNOPULM LTD | Israel | STS | registered |
| Tenovi Co. | – | Tenovi | registered |
| VIVE HEALTH LLC Present in Europe in other categories | United States | VIVE | registered |
| Yiwu Ori-Power Medtech Co.,Ltd. Present in Europe in other categories | China | OP - First aid series | registered |
| AD Supply Group Limited | United Kingdom | – | registered |
| ASIA CONNECTION CO., LTD. | Taiwan | – | registered |
| Aidar Health, Inc | United States | – | registered |
| Airway Management, Inc. | United States | – | registered |
| Alerkan, Ltd. | United States | – | K111587 (2011) |
| Amphenol Critical Medical Technologies, LLC | United States | – | 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 Tian Teng Cang Yue Trading Co., Ltd. | China | – | registered |
| Bernd Richter GmbH | Germany | – | registered |
| BiometerPlus USA, Inc. | United States | – | registered |
| Breathe Me, Ltd. | Israel | – | K180487 (2018) |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CEVA Logistics Netherlands BV | Netherlands | – | registered |
| CHANGZHOU MAJOR MEDICAL PRODUCTS CO., LTD. | China | – | registered |
The 100 most active manufacturers are shown, out of 248.
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