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Emdyca

Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instruments

Endoscopic lithotripsy instruments

EMDN code Z120203

8 manufacturers, 24 models including 23 on the market, 4 countries

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Manufacturers registered in Europe (EUDAMED) 8
  • 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.

ManufacturerCountryBrandsFDA clearance
Northgate Technologies, Inc. United States Autolith Touch Lithotripsy Probe 1.9FR 375cm DS Lithotripsy Probe 1.9FR 120cm Lithotripsy Probe 9FR 54cm Lithotripsy Probe 1.9FR 375cm Lithotripsy Probe 1.9FR 250cm K202813 (2021)
Ultratellege USA Co., Ltd. United States UreTron Flexible Sterile Probe UreTron Semi Rigid Sterile Probe 1.5 x 480 mm UreTron Rigid Sterile Probe 3.5 x 370 mm UreTron Rigid Sterile Probe 3.1 x 370mm UreTron Flexible Sterile Probe 0.8 x 600 mm UreTron Rigid Hand Piece registered
Boston Scientific Corp Present in Europe in other categories United States Rigid Pneumatic Probe Ultrasound Probe Flexible Probe K002084 (2000)
Cybersonics, Inc. United States Cyberwand USL Wrench CyberWand Probe Set CyberWand USL Power Cord CyberWand USL Foot Switch CyberWand USL NoseCone Kit CyberWand USL Generator K171024 (2017)
Cook, Inc. United States StoneBreaker registered
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Present in Europe in other categories China EHL Probe Electrohydraulic Lithotriptor K242888 (2025)
Richard Wolf GmbH Present in Europe in other categories Germany – registered
Medispec, Ltd. United States Lithospec K974796 (1998)
Olympus Medical Systems Corp. Present in Europe in other categories Japan Foot Swtich for LUS-2 registered
Electro Medical Systems SA United States – K012445 (2001)
MDTGlobal, a.s. Slovakia – registered
Medsonics United States – K162119 (2016)
Misonix, Inc. United States – registered
Nissha Medical Technologies Present in Europe in other categories United States – registered
Olympus America, Inc. Present in Europe in other categories United States – K873367 (1987)
Primo Medical Group, Inc United States – registered
Promepla Present in Europe in other categories Monaco – registered
STERIPAC GMBH Germany – registered
SunMed Group Holdings, LLC dba AirLife United States – registered

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