Bioimaging and radiotherapy instrumentsEchography instruments
Ultrasound probes
EMDN code Z110402
Manufacturers registered in Europe (EUDAMED) 34
- 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) 315
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 |
|---|---|---|---|
| CIVCO Medical Instruments Co., Inc. | United States | Needle Guide Biopsy Starter Kit CIV-Flex™ Transducer Cover Needle Guide Starter Kit Transducer Cover Biopsy Bracket | K260114 (2026) |
| JingFang Precision Medical Device(Shenzhen) Co., Ltd. | China | InnoFine Mindray | registered |
| Protek Medical Products, Inc. | United States | Reusable Biopsy Bracket Sterile Disposable Endocavity Needle Guide Reusable Stainless Steel Endocavity Needle Guide Sterile Disposable Endocavity Needle Guide Kit Reusable Multi Angle Biospy Bracket Sterile Disposable Needle Guide | K973958 (1998) |
| Sheathing Technologies, Inc. Present in Europe in other categories | United States | Sheathes Sheathes3D SheathesISO Vital Care Industries | K153212 (2016) |
| ADVANCE MEDICAL DESIGNS, INC. Present in Europe in other categories | United States | Ultrasound Probe Cover Biopsy Needle Guide Ultrasound Probe Cover Biopsy Needle Guide Kit UNBRANDED Soft Flex Probe Cover Rolled Probe Cover Probe Cover | K223689 (2023) |
| Qingdao Hisense Medical Co., Ltd. Present in Europe in other categories | China | Hisense | registered |
| GE Ultrasound Korea Ltd. Present in Europe in other categories | – | LOGIQ Voluson | registered |
| Qingdao Hisense Medical Equipment Co., Ltd. | China | Hisense | registered |
| Alpinion Medical Systems Co., Ltd. Present in Europe in other categories | South Korea | E-CUBE minisono L3-12 SP1-5 CW2.0 SP3-8 | registered |
| Bard Access Systems, Inc. Present in Europe in other categories | United States | Site-Rite Site~Rite 8 Ultrasound System BD Prevue II Peripheral Vascular Access System BD SiteRite 9 Ultrasound System Site~Rite 8 Pinpoint GT Needle Guide Kit | K042445 (2004) |
| Shenzhen Wisonic Medical Technology Co. , Ltd. Present in Europe in other categories | China | WISONIC Diagnostic Ultrasound System Ultrasonic Transducer | registered |
| Olympus Medical Systems Corp. Present in Europe in other categories | Japan | ULTRASONIC PROBE EVIS EUS ENDOSCOPIC ULTRASOUND CENTER Balloon Applicator BALLOON3 Water-resistant Cap BALLOON | K250883 (2025) |
| MEDTRONIC XOMED, INC. Present in Europe in other categories | United States | NIM-ECLIPSE® NIM Eclipse NIM-ECLIPSE | registered |
| Clarius Mobile Health Corp. Present in Europe in other categories | Canada | Clarius Ultrasound Scanner Synergy MSK Ultrasound Scanner Viera Portable Breast Ultrasound Synergy MSK Ultrasound | registered |
| OWENS & MINOR DISTRIBUTION, INC. | – | HALYARD | registered |
| NEWMAN MEDICAL LLC | United States | DigiDop simpleABI | K110628 (2011) |
| Boston Scientific Corp Present in Europe in other categories | United States | AVVIGO™+ AVVIGO™ Guidance System II MDU5 PLUS iNod™ iNod™ Ultrasound Guidance Conso Ultra ICE Plus | K200733 (2020) |
| GE Medical Systems Ultrasound and Primary Care Diagnostics Present in Europe in other categories | United States | Venue LOGIQ Venue Go Venue Fit Venue Sprint | K202035 (2020) |
| Eco-Med Pharmaceutical Inc | – | Ecogel 200 EcoLotion Ecogel 100 EcoGel 200 Clear | registered |
| EXACT MEDICAL MANUFACTURING, INC. | China | Exact Medical Manufacturing, Inc. Proficient Surgical | K222460 (2023) |
| Supersonic Imagine Present in Europe in other categories | France | Aixplorer® Ultimate SL18-5® C6-1X® XC6-1® LV16-5 Transducer SuperSonic HepaVu | K102041 (2010) |
| MedXPress.Pro Present in Europe in other categories | Belgium | EZCOVER® STOP Gel-Free EZCOVER® Gel-Free EZCOVER® Gel-Vision EZCOVER® STOP Gel-Vision | K191491 (2020) |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Bovie | registered |
| TELEMED UAB | – | ArtUs MicrUs SmartUs MicrUs Pro | registered |
| GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETI | – | GTK Disposable Needle Guides | registered |
| C.R. Bard, Inc. | United States | Sure-Point™ Brachy Needle Template Siemens Brachy Needle Template B-K Brachy Probe Cradle B-K 8848 Brachy Probe Cradle GE ERB Brachy Needle Box | K171348 (2017) |
| Coopersurgical, Inc. Present in Europe in other categories | United States | CooperSurgical® Summit Doppler MediChoice LifeDop® 250 ABI system with 2 cuffs, aneroid and printer | registered |
| Biim Ultrasound AS | Norway | Biim Android App, P1.3.2 Biim Android App, P1.1 Probe holder, (V2) Biim Ultrasound Biim Ultrasound L12-4 Linear Array Transducer Biim iOS App, P1.1 Probe Holder, (V1) Biim Ultrasound | registered |
| NATUS NEUROLOGY INCORPORATED Present in Europe in other categories | United States | NATUS NEUROLOGY NATUS NEUROLOGY INCORPORATED | registered |
| Butterfly Network, Inc. Present in Europe in other categories | United States | Butterfly iQ3 Charger Kit Butterfly iQ3 Ultrasound System LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter USB-C CABLE ASSEMBLY, USB 2.0, 1.50 meter BUTTERFLY IQ3 ACCESSORY CABLE, USB-C, USB2.0, 1.50M USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter | registered |
| Esi, Inc. | United States | Prager Shell® PRAGER SHELL® P106SVGS ClearScan® | K082893 (2008) |
| Medisono, LLC Present in Europe in other categories | United States | Medisono | registered |
| Huntleigh Healthcare, Inc. | United Kingdom | DOPPLEX | K201425 (2021) |
| Wuhan United Imaging Healthcare Co., Ltd. Present in Europe in other categories | China | uSONIQUE | registered |
| Wuxi Hisky Medical Technologies Co., Ltd. Present in Europe in other categories | China | Shear Wave Quantificational Ultrasound Diagnostic System Imaging Probe Fibrosis Scanning Probe | registered |
| ECHONOUS, INC. Present in Europe in other categories | United States | Uscan Linear Probe Kosmos Torso-One - USB Uscan Sector Probe (Japan) Kosmos Torso - Refurbished Kosmos Lexsa (Refurbished) Kosmos OTS iOS Software Package (5.0) | registered |
| Ellex Medical Pty, Ltd. Present in Europe in other categories | Australia | Ellex Eye Cubed V4 New Gen 40MHZKIT-USA ACC00042 | registered |
| HOYA CORPORATION | United States | PENTAX PENTAX Medical | registered |
| Leltek, Inc. Present in Europe in other categories | Taiwan | LELTEK ASUS LeSono | registered |
| Qisda Corporation Present in Europe in other categories | Taiwan | InnoSight Diagnostic Ultrasound System Esaote MyLabX1 Ultrasound Transducer_Linear Array Esaote MyLabX1 Ultrasound Transducer_Convex Linear Array C83B Transducer S4-2 Transducer C6-2 Transducer | registered |
| FCU Present in Europe in other categories | South Korea | ACUWAY ACUGUIDE Sono Champion AcuViz Pocket SOFRA1L Sonovation1L | registered |
| PARKS MEDICAL ELECTRONICS, INC. | United States | 2.25MHZ OB PROBE 641 2.15MHZ OB PROBE 641-A 2.20MHZ OB PROBE 641 2.25MHZ OB PROBE 641-A 2.00MHZ OB PROBE 641 2.10MHZ OB PROBE 641 | registered |
| Quantel Medical Present in Europe in other categories | United States | COMPACT TOUCH AVISO (S) COMPACT TOUCH STS LIN 50MHz Probe AXIALIS PROBEAM Biometry Probe | registered |
| Analogic Corp. | United States | Pathfinder Large Multi-Tool Instrument Clamp Sonic Window Sterile Transducer Cover Pathfinder Long Probe Sonic Window Handheld Ultrasound System Pathfinder Shadow Sonic Window Handheld Ultrasound Unit | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Dgh Technology, Inc. Present in Europe in other categories | United States | UBM 35 MHz Transducer 20 MHz B-Scan Probe Scanmate Flex USB Interface DGH 2006 Corded Pachymeter Probe UBM Probe DGH 6006 Corded A-Scan Probe | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| Novasignal Corp. | United States | 2-MHz Transducer, Handheld NovaGuide™ 2 Traditional Ultrasound System Remote Control Accessory 2Mhz Monitoring Transducer - 8 foot NovaGuide™ Intelligent Ultrasound System Temporal Monitoring Headframe | registered |
| Accutome, Inc. | United States | B-scan Pro: Software Package B-scan Pro- VET A-scan Plus Connect B-scan Plus 4Sight B-scan Pro | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | MEDLINE | registered |
| Mendaera, Inc. | United States | Focalist System Software Focalist System Focalist Robot Drape Kit Focalist Probe and Robot Drape Kit Mendaera Robot Drape Kit Mendaera Probe and Robot Drape Kit | K250524 (2025) |
| Exact Imaging, Inc. Present in Europe in other categories | Canada | EV9C Transrectal Transducer EV5C Abdominal Transducer EV29L Transrectal Transducer Sterile transrectal needle guide with sheath Sterile transperineal needle guide with sheath Needle Guide for use with the Exact Imaging EV29L Transducer | registered |
| IMEX, LLC | United States | Imex ELITE 8MHZ VASCULAR PROBE Imex CT+ Doppler Imex Elite 100 Doppler Imex ELITE 2MHZ WATERPROOF PROBE V2 Imex Elite 200 Doppler Elite 5 MHz Vascular Probe | registered |
| Kolo Medical (Suzhou) Co., Ltd. | China | KOLO | registered |
| Shenzhen Delica Medical Equipment Co., Ltd. Present in Europe in other categories | China | Delica | registered |
| CLEAR GUIDE MEDICAL, INC. Present in Europe in other categories | United States | Clear Guide SteriGRID Clear Guide SCENERGY TP Clear Guide TP Access Frame Clear Guide TP Access Posts Clear Guide TP Access Tool | registered |
| MEDA Co., Ltd. Present in Europe in other categories | China | Ultrasonic A/B Scanner for Ophthalmology Ultrasonic Biometer for Ophthalmology Bladder Scanner Ultrasonic Pachymeter Ultrasound Biomicroscope | registered |
| Red Medical Supplies Ltd | – | RED Medical Supplies | registered |
| ACESSA HEALTH INC. | – | Acessa ProVu Handpiece Acessa Pads Acessa ProVu Handpiece Cable Acessa ProVu Planar Field Generator (PFG) Acessa Pad Cable Acessa ProVu PFG Table Clamp | registered |
| Avante | – | Compact II Crystal 4P FS-60 Advance FS-32P | registered |
| Suzhou PeakSonic Medical Technology Co.,LTD. Present in Europe in other categories | China | Bladder Scanner | registered |
| Vave Health, Inc. Present in Europe in other categories | United States | Vave | registered |
| Aco Healthcare Co., Ltd. Present in Europe in other categories | Taiwan | Neo Medical Aco Smartcare | registered |
| Biobot Surgical Pte., Ltd. Present in Europe in other categories | Singapore | iSR'obot Mona Lisa iSR'obot Kit iSR'obot Biopsy Kit | K163502 (2017) |
| GuangDong Youkey Medical Co., Ltd. | China | – | registered |
| Mcube Technology Co., Ltd. Present in Europe in other categories | South Korea | CUBEscan | K111021 (2011) |
| PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE | – | Morpheus® Quickscan Morpheus Pathway® | registered |
| RIMED LTD. | Israel | CW 8MHz Ultrasonic Probe Digi-One Digi-Lite IP Linear Probe PW 2MHz Ultrasonic Probe CW 4MHz Ultrasonic Probe Digi-Lite IP | registered |
| Best Nomos | United States | Sonalis Needle Kit, TargetScan 3, 18 Gauge, 5 Pack Needle Kit, TargetScan 2, 18 Gauge, Single Needle Kit, TargetScan 2, 18 Gauge, 5 Pack Needle Kit, TargetScan 3, 18 Gauge, Single TargetScan Touch | registered |
| Drive Devilbiss Healthcare | United States | Roscoe Medical LG | registered |
| Laborie Medical Technologies Canada ULC | – | NuWav | registered |
| Nidek, Inc. Present in Europe in other categories | United States | A-scan probe ECHOSCAN Pachymetry probe Pachymetry probe (45° fixed type) | registered |
| PRESTIGE AMERITECH, LTD. | United States | PremierPro | registered |
| U.S. OPHTHALMIC, L.L.C. | United States | Gilras Eli Ezer | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| LINKQUEST INC. | United States | Phase Array Linear Array Convex 3D Array Convex Array MicroConvex Array | registered |
| MARKETLAB INC. | United States | Marketlab, Inc | registered |
| National Therapy Products Inc | Canada | Sonicshield Wavelength | K012522 (2001) |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | SMARTNEEDLE | registered |
| Verathon Incorporated Present in Europe in other categories | United States | BladderScan® | registered |
| Astrasono technology co.,ltd. | China | Astrasono A3Essential Bladder Scanner Astrasono A5Pro Bladder Scanner Astrasono A3Pro Bladder Scanner Astrasono A3Pro Lite Bladder Scanner | registered |
| Avanos Medical, Inc. | United States | Halyard | registered |
| CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD Present in Europe in other categories | China | Ophthalmic Ultrasound Examination Instrument | registered |
| CS MEDICAL, LLC | United States | TD 100® TD-5® TD-8® | registered |
| Conavi Medical Inc | Canada | Foresight ICE™ PIM Foresight ICE™ Catheter Foresight ICE™ Hummingbird Console Foresight ICE™ Catheter Accessories Package | registered |
| Contec Medical Systems Co., Ltd. Present in Europe in other categories | China | CONTEC | registered |
| EMAGINE SOLUTIONS TECHNOLOGY LLC | United States | VistaScan™ | registered |
| EdgeCare Inc. Present in Europe in other categories | South Korea | EdgeFlow UH10 EdgeFlow UH10L EdgeFlow UH10S EdgeFlow UW20 | registered |
| Globalmed Holdings, LLC | United States | ClearProbe | registered |
| Mettler Electronics Corp. | United States | Sonigel Ultrasound Gel Couplants | registered |
| Myt Enterprises LLC | – | Medvat | registered |
| Provisio Medical, Inc. | United States | SLT IVUS P1 Display Unit SLT IVUS P1 Pulser Receiver Unit SLT IVUS P1 Cart SLT IVUS Support Crossing Catheter | registered |
| UNETIXS VASCULAR, INC. | United States | Unetixs Vascular | registered |
| US Endoscopy | United States | Ultramatrix Oracle | registered |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED ULTRASOUND | registered |
| Alcon Laboratories, Inc. Present in Europe in other categories | United States | Alcon | registered |
| Beijing East Whale Imaging Technology Co., Ltd. | China | WHALE | registered |
| CADWELL INDUSTRIES, INC. Present in Europe in other categories | United States | Sierra NMUS1 | registered |
| Carbon (Shenzhen) Medical Device Co., Ltd. | China | CarbonMed | registered |
| Caresono Technology Co.,Ltd. | Taiwan | Caresono | registered |
The 100 most active manufacturers are shown, out of 315.
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