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Emdyca

Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instrumentsVarious instruments for endoscopy and mini-invasive surgery

Various instruments for endoscopy and mini-invasive surgery - software accessories

EMDN code Z12029082

2 manufacturers, 5 models including 4 on the market, 1 country

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Manufacturers registered in Europe (EUDAMED) 2
  • 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
Karlstorz FDA Germany IIb MDR Website regulatory@karlstorz.com EUDAMED record Report an error
Richard Wolf FDA Germany IIb 93/42 info@richard-wolf.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) 7

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
Olympus Medical Systems Corp. Present in Europe in other categories Japan INTERFACE FOR ESU (FORCE SERIES) UNIVERSAL INTERFACE VTR remote cable INTERFACE FOR ESU (VIO SERIES) UCES-4 Upgrade Pack 2 MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 K102763 (2011)
Smith & Nephew, Inc. Present in Europe in other categories United States INTELLIO Tablet LENS CONNECTED TOWER APPLICATION K221929 (2022)
BLACK DIAMOND VIDEO, INC. United States – K153205 (2016)
ICU MEDICAL, INC. Present in Europe in other categories United States – registered
MCD Medical Computers Deutschland GmbH Germany – registered
Olympus America, Inc. Present in Europe in other categories United States – registered
Richard Wolf Medical Instruments Corp. United States – K151282 (2016)

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