Echography instrumentsUltrasound scannersUltrasound scanners - hardware accessories
Ultrasound scanners - hardware accessories - other
EMDN code Z1104018099
Manufacturers registered in Europe (EUDAMED) 12
- 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) 21
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 |
|---|---|---|---|
| HOYA CORPORATION | United States | PENTAX PENTAX Medical | registered |
| Boston Scientific Corp Present in Europe in other categories | United States | Expect Slimline SL Expect iNod™ Acquire Acquire™ S iNod™ Ultrasound Guidance Conso | K260428 (2026) |
| Micro-Tech (Nanjing) Co., Ltd. | China | Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) | K212852 (2021) |
| Endosound, Inc. | United States | EndoSound® EVS™ Band Applicator EndoSound® EVSScanner EndoSound® EVS™ Bands EndoSound® Transducer Extension Connector (TEC) EndoSound® Coax Transducer Extension Connector (TEC) EndoSound® Ultrasound Disposable Kit (UDK-T) 5008 | K232518 (2023) |
| Pentax of America, Inc. Present in Europe in other categories | United States | ULTRASOUND GASTROSCOPE | K203166 (2020) |
| Cook, Inc. | United States | EchoTip ClearCore EchoTip AcuCore | registered |
| US Endoscopy | United States | Ultramatrix | registered |
| Sonoscape Medical Corp. Present in Europe in other categories | China | SonoScape | K231813 (2024) |
| APEX MEDICAL TECHNOLOGIES, INC. Present in Europe in other categories | United States | – | registered |
| Adroit USA Inc | United States | – | registered |
| Fuji Latex Co., LTD. | Japan | – | registered |
| HOYA Corporation PENTAX Division | United States | – | registered |
| Ian Jamieson Pty Ltd | Australia | – | registered |
| NZ Biomed Limited | New Zealand | – | registered |
| OMERIN CABLES SAS | France | – | registered |
| Onepass Medical , Ltd. | Israel | – | K251542 (2025) |
| PROBO Medical SAS | France | – | registered |
| STERIS Corporation Present in Europe in other categories | United States | – | registered |
| Sanicure BV | Netherlands | – | registered |
| United States Endoscopy Group, Inc. (Us Endoscopy) Present in Europe in other categories | United States | – | K180731 (2018) |
| Worldwide Supplies Limited | Hong Kong SAR China | – | registered |
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.