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Emdyca

Instruments for functional explorations and therapeutic interventionsUrology instrumentsVarious instruments for urology

Penile tumescence measuring equipment

EMDN code Z12169001

1 manufacturer, 1 model including 1 on the market, 1 country

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Manufacturers registered in Europe (EUDAMED) 1
  • 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
GOTOP Medical FDA EU representative : Atlantico Systems, Ltd. (Ireland) United States IIa MDR Website info@gotopmedical.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) 2

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
Medtech Products, Inc. Present in Europe in other categories United States Nix registered
Virtex United States – registered

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