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Emdyca

Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instrumentsUpper gastrointestinal tract endoscopy instruments

Choledocoscopes

EMDN code Z12020501

12 manufacturers, 16 models including 16 on the market, 3 countries

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Manufacturers registered in Europe (EUDAMED) 12
  • 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
Leinzett EU representative : Caretechion GmbH (Germany) China IIa 93/42 info@leinzett.com EUDAMED record Report an error
Hugemed FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Seegen FDA EU representative : SUNGO Europe B.V. (Netherlands) China IIa MDR Website EUDAMED record Report an error
Alton FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR info@alton.com.cn EUDAMED record Report an error
Guangzhou Red Pine Medical Instrument FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR Website regulation@gzredpine.com EUDAMED record Report an error
Karlstorz FDA Germany IIa MDR Website regulatory@karlstorz.com EUDAMED record Report an error
Micro-Tech (Nanjing) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR Website info@mtmed.com EUDAMED record Report an error
Otumed FDA EU representative : MedNet EC-REP GmbH (Germany) United States IIa MDR sales@otumed.com EUDAMED record Report an error
Promisemed FDA EU representative : Obelis s.a. (Belgium) China IIa MDR EUDAMED record Report an error
Scivitamedical FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR Website info@scivitamedical.com EUDAMED record Report an error
Tuyunmed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR radepartment@tuyunmed.com EUDAMED record Report an error
Zhejiang Geyi Medical Instrument FDA EU representative : MedPath GmbH (Germany) China IIa MDR 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) 20

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
Micro-Tech (Nanjing) Co., Ltd. China Single-use Video Scope eyeMAX(TM) PB Digital Controller K221784 (2023)
Richard Wolf GmbH Present in Europe in other categories Germany RIWO registered
Olympus Medical Systems Corp. Present in Europe in other categories Japan URETERO-RENO FIBERSCOPE Forceps Suction Plug (T-Plug) URETERO-RENO VIDEOSCOPE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE Gas Valve DISPOSABLE GRASPING FORCEPS K113120 (2012)
Boston Scientific Corp Present in Europe in other categories United States SpyGlass DS SpyGlass™ Discover SpyScope DS SpyScope™ DS II K200483 (2020)
Gyrus Acmi, Inc. Present in Europe in other categories United States Gyrus ACMI registered
HOYA CORPORATION United States PENTAX registered
CENTERPOINT SYSTEMS LLC United States Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps K233752 (2024)
Pentax of America, Inc. Present in Europe in other categories United States FIBER PANCREATOSCOPE registered
Tangent Endoscopy, LLC United States Tangent Digital catheter K251170 (2025)
Cordica Medical (Formally Team Technologies, Inc) United States – registered
ENERCON TECHNOLOGIES United States – registered
Endocure Technologies, Inc. United States – K161147 (2016)
HOYA Corporation PENTAX Division United States – registered
Ian Jamieson Pty Ltd Australia – registered
Mirco-Tech (Nanjing) Co., Ltd. China – K254153 (2026)
Ningbo Wise Optomech Technology Corporation Present in Europe in other categories China – registered
Olympus America, Inc. Present in Europe in other categories United States – K944473 (1995)
Shanghai AnQing Medical Instrument Co., Ltd. Present in Europe in other categories China – K231105 (2023)
Shenzhen Besdata Technology Co., Ltd. Present in Europe in other categories China – registered
Zhuhai Pusen Medical Technology Co., Ltd. Present in Europe in other categories China – K223741 (2023)

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