Instruments for functional explorations and therapeutic interventionsUrology instruments
Extracorporeal lithotripsy instruments
EMDN code Z121601
Manufacturers registered in Europe (EUDAMED) 9
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 16
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 |
|---|---|---|---|
| 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 |
| Medispec, Ltd. | United States | Econolith EM1000 Econolith E3000 Econolith E2000 | K063504 (2007) |
| Direx Systems Corp. | United States | TRIPTER X-1 COMPACT COMPACT DUET DUET MAGNA INTEGRA | K111947 (2012) |
| MTS Medical AG | Germany | MTS | 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 |
| ELvation Medical GmbH | Germany | – | registered |
| Huons USA | United States | – | registered |
| Initia, Ltd. | Israel | – | registered |
| KARL STORZ Endoscopy-America, Inc. | United States | – | K201001 (2021) |
| Lite-Med, Inc. | Taiwan | – | K213772 (2023) |
| Siemens Healthineers AG Present in Europe in other categories | Germany | – | registered |
| Sonomotion, Inc. | United States | – | K261086 (2026) |
| Tissue Regeneration Technologies, LLC | United States | – | K062081 (2006) |
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