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Emdyca

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

Ultrasonic endoscopic lithotripters

EMDN code Z12020302

4 manufacturers, 18 models including 18 on the market, 3 countries

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Manufacturers registered in Europe (EUDAMED) 4
  • 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.
ManufacturerCountryRegistered modelsClassContact
Gyrus ACMI FDA EU representative : Olympus Europa SE & Co. KG (Germany) United States
8 others
 IIa, IIb 93/42 EUDAMED record Report an error
E.M.S. Electro Medical Systems FDA EU representative : EMS FRANCE SARL (France) Switzerland I MDR Website EUDAMED record Report an error
Elmed Elektronik Ve Medikal San Tic Türkiye IIb 93/42 Website EUDAMED record Report an error
Incelermedikal Türkiye IIb 93/42 Website quality@incelermedikal.com 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) 11

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
Karl Storz GmbH & Co. KG Present in Europe in other categories Germany n.a. CALCUSON registered
Olympus Medical Systems Corp. Present in Europe in other categories Japan Foot Swtich for LUS-2 registered
Cybersonics, Inc. United States – K171024 (2017)
Electro Medical Systems SA United States – registered
MDTGlobal, a.s. Slovakia – registered
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
Richard Wolf GmbH Present in Europe in other categories Germany – registered

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