Instruments for functional explorations and therapeutic interventions
Urology instruments
EMDN code Z1216
Manufacturers registered in Europe (EUDAMED) 30
- 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) 56
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 |
|---|---|---|---|
| Laborie Medical Technologies Canada ULC | – | Air-Charged Reusable Cable Pump Tube Set Cystometry Pack Triton Aquarius XT 2-lumen Cystometry Pack | registered |
| Medical Systems Corp. Present in Europe in other categories | United States | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | K072538 (2008) |
| UNITED SERVICE SOLUTIONS, LLC | United States | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE | registered |
| Unisensor AG | United States | UniTip Catheter | registered |
| MEDIPLUS LTD | United States | Mediplus Morpheus | registered |
| Medical Measurement Systems B.V. | Netherlands | Solar Silver L4, Trolley system Flowmaster NS Nexam Pro WPU, trolley system Solar Blue, Table top Solar Uroflow system Nexam Pro CIM, trolley system | registered |
| Coopersurgical, Inc. Present in Europe in other categories | United States | Lumax TS Pro Lumax™ TS Pro Lumax Infusion Transducer Hand Held Remote Lumax™ TS Pro Advanced | registered |
| C.R. Bard, Inc. | United States | Bard® Urodynamic Catheter, Triple Lumen Bard® Urodynamic Pump Tubing Set Bard® Urodynamic Catheter, Double Lumen Bard® Urodynamic Catheter, Single Lumen | K924714 (1993) |
| Medispec, Ltd. | United States | Econolith EM1000 Econolith E3000 Econolith E2000 | K063504 (2007) |
| PendraCare International B.V. | – | e∙Sense | registered |
| Direx Systems Corp. | United States | TRIPTER X-1 COMPACT COMPACT DUET DUET MAGNA INTEGRA | K111947 (2012) |
| Gemini Medical Technologies LLC | United States | Atmos | registered |
| Well Lead Medical Co.,Ltd | China | Wellead Urodynamic Catheter | registered |
| Medtech Products, Inc. Present in Europe in other categories | United States | Nix | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | RUSCH | registered |
| Cook, Inc. | United States | Cook | registered |
| DELTA MED SPA Present in Europe in other categories | Italy | Securmeter Foley Manometer | registered |
| ICU MEDICAL, INC. Present in Europe in other categories | United States | Laborie | registered |
| MTS Medical AG | Germany | MTS | registered |
| NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | United States | AED | registered |
| PRINCE MEDICAL | – | CATHETER POUR CYSTOMETRIE 2 VOIES CH 6 | registered |
| Promepla Present in Europe in other categories | Monaco | WATER PUMP TUBIG KIT | registered |
| SRS Medical Systems, Inc. | United States | CT3000 Pro Base Unit | registered |
| Shenzhen Wikkon Precision Technologies Co., Ltd. | China | Extracorporeal Shock Wave Lithotripter | K242922 (2025) |
| Siemens Healthcare GmbH Present in Europe in other categories | Germany | Modularis Variostar | registered |
| Suzhou Xixin Medical Instruments Co., Ltd. | – | Extracorporeal Shock Wave Lithotripter | registered |
| ALACER INDUSTRIA ELETRONICA LTDA | Brazil | – | registered |
| AMECO MEDICAL INDUSTRIES | Egypt | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| BIOTEQUE CORP | Taiwan | – | registered |
| CLINICAL INNOVATIONS, LLC Present in Europe in other categories | United States | – | registered |
| COGENTIX MEDICAL, INC. Present in Europe in other categories | United States | – | registered |
| Convatec Present in Europe in other categories | United States | – | registered |
| Creation Technologies | Canada | – | registered |
| Demcon Production B.V. | Netherlands | – | registered |
| ELvation Medical GmbH | Germany | – | registered |
| Huons USA | United States | – | registered |
| IIMED MEDICAL MEXICANA S. DE R.L. DE C.V. | Mexico | – | registered |
| Initia, Ltd. | Israel | – | registered |
| KARL STORZ Endoscopy-America, Inc. | United States | – | K201001 (2021) |
| Lite-Med, Inc. | Taiwan | – | K213772 (2023) |
| Lotus US Bidco Inc. | United States | – | registered |
| Medica Corp. | United States | – | registered |
| Medica Mediterranee | Tunisia | – | registered |
| Meridian Medical d.o.o. Present in Europe in other categories | United Kingdom | – | registered |
| OMERIN CABLES SAS | France | – | registered |
| PB Medical Ltd | United Kingdom | – | registered |
| Rheme GmbH | Germany | – | registered |
| STATUS MEDICAL EQUIPMENTS INDIA PRIVATE LIMITED | India | – | registered |
| Siemens Healthineers AG Present in Europe in other categories | Germany | – | registered |
| Sonomotion, Inc. | United States | – | K261086 (2026) |
| Srs Medical | United States | – | K212830 (2021) |
| The Prometheus Group Present in Europe in other categories | United States | – | registered |
| Tissue Regeneration Technologies, LLC | United States | – | K062081 (2006) |
| Virtex | United States | – | registered |
| Vivachek Biotech (Hangzhou) Co., Ltd. Present in Europe in other categories | China | – | registered |
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