Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instruments
Pulmonary endoscopic instruments
EMDN code Z120208
Manufacturers registered in Europe (EUDAMED) 46
- 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) 74
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 |
|---|---|---|---|
| EFER ENDOSCOPY | France | Silicone cap Adult bronchial tube Adult introducer tube Adult loader Adult plunger tube Adult tracheal tube | registered |
| Auris Health, Inc. | United States | Bronchoscope Fluidics Tubing Monarch Bronchscope 2.0/Monarch Platform (P2) Bronchoscope Sheath Valve Monarch Bronchoscope Monarch Software Tower v2.1.6 Monarch™ Tower Software v4.1.1 | K260382 (2026) |
| Boston Scientific Corp Present in Europe in other categories | United States | Exalt ™ EXALT™ eXcelon EXALT™ Model B Expect Pulmonary Expect Pulmonary Adaptor | K221340 (2023) |
| HOYA CORPORATION | United States | PENTAX PENTAX Medical INSPIRA | registered |
| Pentax of America, Inc. Present in Europe in other categories | United States | VIDEO BRONCHOSCOPE FIBER BRONCHOSCOPE ULTRASOUND BRONCHOSCOPE | K232860 (2024) |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | PILLING | registered |
| Broncus Medical, Inc. | United States | BroncTru™ Transbronchial Access Tool BioStar Transbronchial Aspiration Needle Archimedes Access Kit Archimedes Dilation Balloon Archimedies Access Kit with Syringe FleXNeedle | K232601 (2024) |
| COGENTIX MEDICAL, INC. Present in Europe in other categories | United States | EndoSheath Technology UNITY 9000 UNITY 9100 | registered |
| Conmed Corporation Present in Europe in other categories | United States | WANG CONMED | registered |
| Bodyvision Medical , Ltd. Present in Europe in other categories | Israel | LungVision Tool | K172955 (2018) |
| BRYAN MEDICAL, INC. | United States | Aeris Balloon Dilation Catheter | registered |
| Covidien, LLC Present in Europe in other categories | United States | Arcpoint CrossCountry GenCut | K163537 (2017) |
| SOPRO-COMEG GmbH | Germany | Bronchoscope | registered |
| Noah Medical | United States | Galaxy System - HK Bronchoscope guide Accessory Kit Bronchoscope Bronchoscope connector Galaxy System | K223144 (2023) |
| Bosma Enterprises | – | Ambu | registered |
| Micro-Tech (Nanjing) Co., Ltd. | China | Single-Use Video Bronchoscope | registered |
| Shenzhen Insighters Medical Technology Co., Ltd. Present in Europe in other categories | China | Insighters | K242793 (2025) |
| Hobbs Medical, Inc. | United States | Hobbs Medical Mistifier Spray Catheter | registered |
| Prosurg, Inc. | United States | Neoscope | K152466 (2016) |
| Anrei Medical(HZ) Co.,Ltd. | – | Rescue | registered |
| Cook, Inc. | United States | Captura | K031966 (2003) |
| Dornier Medtech America, Inc. Present in Europe in other categories | United States | Dornier MedTech | registered |
| KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED | United Kingdom | Olympus | registered |
| Mercator Medsystems, Inc. | United States | Blowfish Micro-Infusion Catheter | K131401 (2013) |
| Serpex Medical | United States | Recon Steerable Sheath | K221302 (2022) |
| Veran Medical Technologies, Inc. | United States | SPiN Vision Video Processor | K202346 (2021) |
| Ackermann Instrumente GmbH Present in Europe in other categories | United States | – | registered |
| Anrei Medical (Hangzhou) Co., Ltd. | China | – | K202987 (2021) |
| Auris Surgical Robotics, Inc. | United States | – | K173760 (2018) |
| Biomerics | United States | – | registered |
| Body Vision Medical LungVision Tool Manufacturing | Israel | – | registered |
| BriteMED Technology Inc. Present in Europe in other categories | Taiwan | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CENTERPOINT SYSTEMS LLC | United States | – | registered |
| CHG-MERIDIAN CANADA LTD | Canada | – | registered |
| COMMAND MEDICAL PRODUCTS, LLC | United States | – | registered |
| COOK ENDOSCOPY | United States | – | registered |
| Contra Healthcare Solutions, LLC | United States | – | K243541 (2025) |
| Creation Technologies | Canada | – | registered |
| Elucent Medical, Inc. | United States | – | K260565 (2026) |
| FLEXICARE MEDICAL LIMITED Present in Europe in other categories | United Kingdom | – | K254026 (2026) |
| Free Flow Medical, Inc. | United States | – | K254037 (2026) |
| Fuji Latex Co., LTD. | Japan | – | registered |
| Fujifilm Corporaton | Japan | – | K220957 (2022) |
| GLASER AG | Germany | – | registered |
| HOYA Corporation PENTAX Division | United States | – | registered |
| Harada | Japan | – | registered |
| Harwood Design, Inc. | United States | – | registered |
| Horizons Intl. Corp. | United States | – | K022546 (2002) |
| Ian Jamieson Pty Ltd | Australia | – | registered |
| KARL STORZ Endoscopy-America, Inc. | United States | – | K212656 (2021) |
| Kunststoff Helmbrechts AG | Germany | – | registered |
| MDTGlobal, a.s. | Slovakia | – | registered |
| Medical Resale PTY Limited | Australia | – | registered |
| Medical Wholsale Suplies, Inc, | Canada | – | registered |
| Micro-Tech (Nanjing) Co., Lts | China | – | K213782 (2022) |
| NZ Biomed Limited | New Zealand | – | registered |
| Ningbo Wise Optomech Technology Corporation Present in Europe in other categories | China | – | registered |
| PLEXUS CORP. | United States | – | registered |
| PROBO Medical SAS | France | – | registered |
| Polimeros Formula de Tecate, SA de CV | Mexico | – | registered |
| Primo Medical Group, Inc | United States | – | registered |
| QSA SURGICAL (PVT) LTD. | Pakistan | – | registered |
| SCHOTT CR, s.r.o. | Czechia | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Shenzhen Sanping Image Technology Co., Ltd. | China | – | K242010 (2025) |
| Spiration, Inc. | United States | – | K171492 (2017) |
| Straits Orthopaedics (Mfg) Sdn Bhd | Malaysia | – | registered |
| SunMed Group Holdings, LLC dba AirLife | United States | – | registered |
| TONTARRA MEDIZINTECHNIK GMBH Present in Europe in other categories | Germany | – | registered |
| VEENAK INTERNATIONAL LIMITED | United Kingdom | – | registered |
| Viant Medical, LLC | United States | – | registered |
| Wilson-Cook Medical, Inc. | United States | – | K163377 (2018) |
| addn solutions GmbH & Co. KG | Germany | – | registered |
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