Bioimaging and radiotherapy instrumentsEchography instrumentsUltrasound probes
Transcutaneous ultrasound probes
EMDN code Z11040201
Manufacturers registered in Europe (EUDAMED) 25
- 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) 19
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 |
|---|---|---|---|
| JingFang Precision Medical Device(Shenzhen) Co., Ltd. | China | InnoFine Mindray | registered |
| Sheathing Technologies, Inc. Present in Europe in other categories | United States | Sheathes Sheathes3D | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Exact Imaging, Inc. Present in Europe in other categories | Canada | Sterile transrectal needle guide with sheath Sterile transperineal needle guide with sheath Needle Guide for use with the Exact Imaging EV29L Transducer EV29L Non-Sterile Reusable PrecisionPoint Adapter EV29L Non-Sterile Reusable Transperineal Needle Guide Reusable Needle Guide for use with the Exact Imaging EV29L Transducer | registered |
| Biobot Surgical Pte., Ltd. Present in Europe in other categories | Singapore | iSR'obot Kit iSR'obot Biopsy Kit iSR'obot Mona Lisa | registered |
| CLEAR GUIDE MEDICAL, INC. Present in Europe in other categories | United States | Clear Guide SteriGRID Clear Guide TP Access Tool | registered |
| RF Medical Co., Ltd. Present in Europe in other categories | South Korea | Moving-Shot Guide | registered |
| MEDAX SRL UNIPERSONALE | Italy | MED-GUIDE 1 | registered |
| AGITO Medical A/S | Denmark | – | registered |
| Danelis Medical Limited | United Kingdom | – | registered |
| EverX / Bindra | Australia | – | registered |
| GLOBAL TECH PLASTIC INDUSTRY SDN BHD | Malaysia | – | registered |
| LBN Medical ApS | Denmark | – | registered |
| Pilson Direct Trading Limited | United Kingdom | – | registered |
| SONELE Inc. | Canada | – | registered |
| STS Corporation | United States | – | registered |
| Shenzhen Wisonic Medical Technology Co. , Ltd. Present in Europe in other categories | China | – | registered |
| TransducerWorks | United States | – | registered |
| Well Lead Medical Co.,Ltd | China | – | registered |
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