Bioimaging and radiotherapy instrumentsEchography instrumentsUltrasound scanners
Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
EMDN code Z11040104
Manufacturers registered in Europe (EUDAMED) 31
- 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) 43
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 |
|---|---|---|---|
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | ARROW | registered |
| Boston Scientific Corp Present in Europe in other categories | United States | OptiCross™ HD OptiCross™ 6 HD OptiCross 6 OptiCross OptiCross 18 Fluid Dock | K260816 (2026) |
| Siemens Medical Solutions USA, Inc. Present in Europe in other categories | United States | AcuNav G 10F Ultrasound Catheter AcuNav G 8F Ultrasound Catheter AcuNav Crystal Ultrasound Catheter AcuNav 10F Ultrasound Catheter AcuNav CRYSTAL G Ultrasound Catheter ACUSON P500 ICE Ultrasound System | K261696 (2026) |
| Biosense Webster, Inc. Present in Europe in other categories | United States | SOUNDSTAR NUVISION NAV Ultrasound Catheter NUVISION Ultrasound Catheter SOUNDSTAR CRYSTAL Ultrasound Catheter NuVision ICE Catheter NuVision Connector Cable | K241540 (2024) |
| Acist Medical Systems, Inc. Present in Europe in other categories | United States | ACIST HDi® HD IVUS System ACIST Kodama® Coronary Imaging Catheter ACIST HDi® Bed Rail Mount Kodama Catheter | K193183 (2020) |
| Conavi Medical Inc | Canada | Novasight Hybrid™ Catheter Novasight Hybrid™ Hummingbird Console Novasight Hybrid™ PIM Novasight Hybrid™ Catheter PIM Bag Novasight Hybrid™ Catheter Accessories Package | K252945 (2026) |
| CD Leycom | Netherlands | 7 Fr PV-Catheter 4 Fr PV Catheter | K030524 (2003) |
| NORTH EAST SCIENTIFIC INC | United States | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter NES Reprocessed Eagle Eye Platinum Short Tip Stryker NES Reprocessed .035 Stryker Catheter NES Reprocessed Visions PV .018 Digital IVUS Catheter | K200195 (2020) |
| Ge Vingmed Ultrasound AS Present in Europe in other categories | Norway | Vivid | registered |
| Provisio Medical, Inc. | United States | SLT IVUS P1 Display Unit SLT IVUS P1 Pulser Receiver Unit SLT IVUS P1 Cart | K233948 (2024) |
| ROBERT BUSSE & CO., INC. | United States | Busse Hospital Disposables | registered |
| STRYKER SUSTAINABILITY SOLUTIONS, INC. | United States | Philips Healthcare | registered |
| Volcano Corporation | United States | ComboMap Pressure and Flow System S5 IMAGING SYSTEM P/N 807300001 s5i Imaging System | K160583 (2016) |
| IRVINE BIOMEDICAL, INC. | – | ViewFlex™ | registered |
| Nipro Vascular Innovations Americas, Inc. | United States | TVC Imaging System™ | registered |
| Jiangsu Tingsn Technology Co., Ltd. | China | Disposable Intracardiac Echocardiography Catheter | K250913 (2025) |
| Volcarica S.R.L. | – | Refinity Rotational Intravascular Ultrasound IVUS Catheter | registered |
| ABBOTT MEDICAL Present in Europe in other categories | United States | – | K251211 (2025) |
| Abbott Laboratories Present in Europe in other categories | United States | – | registered |
| Arrow International LLC (subsidiary of Teleflex Incorporated Present in Europe in other categories | United States | – | K132133 (2013) |
| Can Technomed Trading LTD. | Canada | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| Danelis Medical Limited | United Kingdom | – | registered |
| ETHICON, Inc. | United States | – | registered |
| EverX / Bindra | Australia | – | registered |
| Fujikura Fiber Optics VietNam Ltd | Vietnam | – | registered |
| HUMANSCAN CO., LTD Present in Europe in other categories | United States | – | registered |
| Irvine Biomedical, A St. Jude Medical Company | United States | – | K223077 (2022) |
| LBN Medical ApS | Denmark | – | registered |
| Luma Vision Limited | Ireland | – | K261849 (2026) |
| MEDFACT ENGINEERING GMBH Present in Europe in other categories | Germany | – | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | – | registered |
| Medical Resale PTY Limited | Australia | – | registered |
| Medical Wholsale Suplies, Inc, | Canada | – | registered |
| Nuvera Medical, Inc. | United States | – | K201775 (2021) |
| Oldelft Corp. of America Present in Europe in other categories | United States | – | registered |
| PROBO Medical SAS | France | – | registered |
| Pathway Medtech, LLC. | United States | – | registered |
| Pilson Direct Trading Limited | United Kingdom | – | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | – | registered |
| TERUMO CORPORATION Present in Europe in other categories | United States | – | registered |
| Volcano Corporation (Dba Philips Image Guided Therapy Device | United States | – | K253399 (2025) |
| Yorlabs, Inc. | United States | – | K250955 (2025) |
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