Bioimaging and radiotherapy instrumentsEchography instruments
Various ultrasound instruments
EMDN code Z110490
Manufacturers registered in Europe (EUDAMED) 44
- 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) 42
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 |
|---|---|---|---|
| National Therapy Products Inc | Canada | Wavelength | K013212 (2002) |
| Pharmaceutical Innovations, Inc. | United States | Pharmaceutical Innovations | K163026 (2018) |
| HR PHARMACEUTICALS INC. | United States | EcoVue EcoVue HV HR Ultrasound Jelly | K181363 (2018) |
| Bracco Diagnostics Inc. Present in Europe in other categories | United States | E-Z-SCAN Low Viscosity UltraSound Gel E-Z-GEL UltraSound Gel | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline MEDLINE INDUSTRIES, INC. | registered |
| St Jude Medical | United States | ViewFlex™ | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| OWENS & MINOR DISTRIBUTION, INC. | – | Medichoice | registered |
| Dukal LLC | United States | Dukal | registered |
| Dynarex Corporation | United States | Ultrasound Gel | K102637 (2011) |
| Sheathing Technologies, Inc. Present in Europe in other categories | United States | SheathesGel | K130041 (2013) |
| Bard Access Systems, Inc. Present in Europe in other categories | United States | PinPoint | registered |
| Coopersurgical, Inc. Present in Europe in other categories | United States | WALLACH® Summit Doppler™ Ultrasound Gel 60 grams WALLACH® Summit Doppler™ Ultrasound Gel 250 grams | registered |
| Drive Devilbiss Healthcare | United States | GelShot | registered |
| Mettler Electronics Corp. | United States | Sonigel Lotion with Aloe Vera | registered |
| Performance Health Supply Present in Europe in other categories | United States | METRON | registered |
| SME, INC. USA | – | SME | registered |
| STRADIS MEDICAL, LLC | – | Stradis Medical, LLC. | registered |
| Scriphessco | – | Scrip Hessco | registered |
| ADVANCE MEDICAL DESIGNS, INC. Present in Europe in other categories | United States | Asonic Gel | K163050 (2017) |
| CLINICAL HEALTH SERVICES, INC. Present in Europe in other categories | – | CLINICAL HEALTH SERVICES, INC. | registered |
| Dynatronics Corp. | United States | Dynatron® Lotion, 1 Gallon | registered |
| EdgeCare Inc. Present in Europe in other categories | South Korea | EdgeFlow Gel Pad | K252337 (2026) |
| Manamed, Inc. | United States | ManaMed Inc | registered |
| PRESTIGE AMERITECH, LTD. | United States | PremierPro | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| Anhui Deepblue Medical Technology Co., Ltd. Present in Europe in other categories | China | – | K242167 (2024) |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| Foshan Pingchuang Medical Technology Co., Ltd. Present in Europe in other categories | China | – | K253255 (2026) |
| HR Pharmaceuticals, Inc d/b/a HR HealthCare | United States | – | registered |
| Hony Medical Co., Ltd. | China | – | K241789 (2024) |
| Jianerkang Medical Co., Ltd. | China | – | K232957 (2023) |
| Jkh Health Co., Ltd. Present in Europe in other categories | China | – | registered |
| Maquet Critical Care AB Present in Europe in other categories | United States | – | registered |
| Ming Fai Enterprise International Co., Ltd. | Hong Kong SAR China | – | registered |
| PHARMASEPT LTD. MEDICAL PRODUCTS | Israel | – | registered |
| Pharmazeutische Fabrik Montavit Ges.m.b.H. | Austria | – | registered |
| Quotient Medical | Canada | – | K151070 (2016) |
| Top-Rank Health Care Co., Ltd. Present in Europe in other categories | China | – | K260575 (2026) |
| Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler | Türkiye | – | registered |
| Ultrast, Inc. | United States | – | K211691 (2021) |
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