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Emdyca

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

Genitourinary endoscopy instruments - hardware accessories

EMDN code Z12020780

9 manufacturers, 55 models including 55 on the market, 5 countries

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Manufacturers registered in Europe (EUDAMED) 9
  • 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
Olympus Winter & Ibe FDA Germany
14 others
I, IIa MDR, 93/42 Website eudamed.regulatoryaffairs@olympus-oste.eu EUDAMED record Report an error
Erbe Vision FDA Germany
5 others
I, IIa MDR, 93/42 Website info.vision.de@erbegroup.com EUDAMED record Report an error
Karlstorz FDA Germany
3 others
I, IIa MDR Website regulatory@karlstorz.com EUDAMED record Report an error
Hangzhou Hawk Optical Electronic Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
1 other
I MDR Website EUDAMED record Report an error
Schoelly FDA Germany I, IIa MDR Website info@schoelly.de EUDAMED record Report an error
Boston Scientific FDA EU representative : Boston Scientific Limited (Ireland) United States I, IIa MDR Website eudamed@bsci.com EUDAMED record Report an error
Cogentix Medical FDA EU representative : Medical Measurement Systems B.V. (Netherlands) United States I MDR EUDAMED record Report an error
Medimaging Integrated Solution FDA EU representative : MedNet EC-REP GmbH (Germany) Taiwan IIa MDR ra@miis.com.tw EUDAMED record Report an error
Olympus FDA EU representative : Olympus Europa SE & Co. KG (Germany) Japan IIa MDR, 93/42 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) 12

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
Richard Wolf GmbH Present in Europe in other categories Germany E-LINE GREENLIGHT MIDI-SIZE PANOVIEW PLUS MOXY registered
Gyrus Acmi, Inc. Present in Europe in other categories United States USA Elite Gyrus ACMI Elite Iglesias Elite Elite Bipolar registered
Usgi Medical, Inc. United States Transport Endoscopic Access Device registered
Alleima Karlsruhe GmbH Germany – registered
Gi Scientific, LLC United States – K183171 (2019)
INSIGHTRA MEDICAL, INC. United States – registered
KARL STORZ Endoscopy-America, Inc. United States – K131364 (2014)
Lumenr, LLC United States – K153698 (2016)
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Türkiye – registered
Nissha Medical Technologies Present in Europe in other categories United States – registered
Sheathing Technologies, Inc. Present in Europe in other categories United States – registered
medi-G GmbH Germany – registered

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