Devices for urogenital system
EMDN code U
Manufacturers registered in Europe (EUDAMED) 6
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| SmartMann | Germany | I MDR | Website info@smartmann-medical.de EUDAMED record Report an error | |
| Femeda EU representative : CS Life Sciences Europe Ltd (Ireland) | United Kingdom (ex Northern Ireland) |
|
IIa 93/42 | Website info@femeda.com EUDAMED record Report an error |
| InMode FDA EU representative : AR Experts B.V. (Netherlands) | Israel | IIa MDR | Website EUDAMED record Report an error | |
| Medica | Italy | IIa MDR | Website EUDAMED record Report an error | |
| Sapi Med FDA | Italy | I MDR | Website EUDAMED record Report an error | |
| X6 Innovations FDA | France |
|
I MDR | EUDAMED record Report an error |
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) 70
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 |
|---|---|---|---|
| Everyway Medical Instruments Co.,Ltd | Taiwan | Lifecare iSTIM Everyway Intimd | K213116 (2021) |
| EMC EVOLUTION | – | EMC EVOLUTION | registered |
| Incontrol Medical, LLC | United States | Apex®M InTone®MV by Viveve Attain InTone® NASP InTone® by Viveve Apex®M by Viveve | K182022 (2019) |
| BTL Industries, Inc. Present in Europe in other categories | United States | BTL Chair Applicator HPM-6000U BTL EMSELLA HPM-6000U Applicator Chair | K262353 (2026) |
| Dolanvy (Suzhou) Medical Technology Co.,Ltd. | China | DLR | K252831 (2026) |
| PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE | – | Pathway® Pathway Morpheus | registered |
| Utah Medical Products, Inc. Present in Europe in other categories | United States | LIBERTY | K970077 (1997) |
| ZMI ELECTRONICS LTD. Present in Europe in other categories | Taiwan | Levina | K241862 (2025) |
| Drive Devilbiss Healthcare | United States | Richmar EMG Pro | registered |
| MAGIC RACE LLC | – | NeoControl | registered |
| Fotona D.O.O. Present in Europe in other categories | Slovenia | QuantumStar, StarFormer StarFormer | K234061 (2024) |
| Inmode MD , Ltd. | Israel | vTone Adapter HP vTone Tip | registered |
| Laborie Medical Technologies Corp. Present in Europe in other categories | United States | Urostym EMG Stimulation Cable, Ch 1 Urostym EMG Cable, Ch 2 | K070331 (2007) |
| Relevium Labs, Inc. | United States | Yarlap I Yarlap II | registered |
| EasyMed Instruments Co., Ltd. Present in Europe in other categories | China | Intrelief PFE | K241899 (2024) |
| HOME SKINOVATIONS LTD | Israel | Silk'n | registered |
| Hush Tech LLC | – | WAVE | registered |
| Laborie Medical Technologies Canada ULC | – | Urostym | registered |
| ZYNEX MEDICAL, INC. | United States | InWave | K121820 (2012) |
| Zimmer Medizinsysteme GmbH Present in Europe in other categories | Germany | MFG-05 | K230780 (2023) |
| AMARIGO INC | United States | – | registered |
| Ami Polymer Pvt Ltd | India | – | registered |
| Axion USA LLC Present in Europe in other categories | United States | – | registered |
| DJO, LLC | United States | – | registered |
| DONGGUAN AOBO TECHNOLOGY CO.,LTD | China | – | registered |
| Dongguan Dingfoo Plastic Products Co., Ltd. | China | – | registered |
| Everyway Medical Instrument Co., Ltd. Present in Europe in other categories | Taiwan | – | K161349 (2017) |
| Ewig Industries Co. , Ltd. | Hong Kong SAR China | – | registered |
| FOREFRONT MEDICAL TECHNOLOGY (PTE) LTD. | Singapore | – | registered |
| Fuji Dynamics Limited | China | – | K161055 (2016) |
| Generalnet Co., Ltd. | South Korea | – | registered |
| Guangzhou Zhongshu E-Commerce Co., Ltd. | China | – | registered |
| HOBIAN S.R.L. | Romania | – | registered |
| Heartland Technology Dongguan Co.,Ltd. | China | – | registered |
| Hong Kong YanKang Medical Limited | Hong Kong SAR China | – | registered |
| IntelliCare Co., Ltd. | Hong Kong SAR China | – | registered |
| International Trade Group, Inc. | United States | – | K160773 (2016) |
| JM SUNFLOWER LIMITED | Hong Kong SAR China | – | registered |
| Lady Technologies, Inc. | United States | – | registered |
| MED-LINKET CORP | United States | – | registered |
| MysteryVibe Limited | United Kingdom | – | registered |
| Nanjing Vishee Medical Technology Co., Ltd. | China | – | K230767 (2023) |
| Netop Industrial Company Limited Present in Europe in other categories | China | – | registered |
| Ningbo Hanyue Medical Technology Co., Ltd. | China | – | registered |
| Ningbo Luke Medical Devices Co., Ltd. | China | – | registered |
| Oriental Inspiration Limited | China | – | K213133 (2022) |
| P Scientific Sdn. Bhd. | Malaysia | – | registered |
| P. GOPALDAS LTD. | Hong Kong SAR China | – | registered |
| PonteMed AG | Switzerland | – | registered |
| Pontemedag | Switzerland | – | K252334 (2026) |
| React Innovations | United States | – | registered |
| SHENZHEN BESTON E-COMMERCE CO., LTD | China | – | registered |
| SHENZHEN JIDING ELECTRONIC CO.,LTD. | China | – | registered |
| SHENZHEN S-HANDE TECHNOLOGY CO.,LTD | China | – | registered |
| Savantini Holdings Limited | United Kingdom | – | registered |
| Shenzhen CanWin Health Products Co., Ltd | China | – | registered |
| Shenzhen Changkun Technology Co., Ltd. Present in Europe in other categories | China | – | K252552 (2026) |
| Shenzhen Dongdixin Technology Co., Ltd. Present in Europe in other categories | China | – | K171430 (2018) |
| Shenzhen Hongzhun Zhizao Technology Co., Ltd | China | – | registered |
| Shenzhen Linglu Hongtu Technology Co., Ltd | China | – | registered |
| Shenzhen Med-Link Electronics Tech Co., Ltd. Present in Europe in other categories | China | – | K210441 (2021) |
| Silkn Beauty Ltd. Present in Europe in other categories | Netherlands | – | registered |
| TIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO.,LTD. Present in Europe in other categories | China | – | registered |
| TOPARC TECHNOLOGY (SHENZHEN) CO.,LTD | China | – | registered |
| The Prometheus Group Present in Europe in other categories | United States | – | K030039 (2003) |
| Think Big Industrial Company Limited | China | – | registered |
| Trinity Medical Solutions | United States | – | K251026 (2025) |
| Verity Medical , Ltd. Present in Europe in other categories | Ireland | – | K243079 (2025) |
| Well-Life Healthcare Limited | Taiwan | – | K251760 (2026) |
| Xi'an Furuize Biotechnology Co., Ltd. | China | – | registered |
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