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Emdyca

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

Colposcopes

EMDN code Z12020703

25 manufacturers, 41 models including 41 on the market, 12 countries

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Manufacturers registered in Europe (EUDAMED) 25
  • 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
Alltion FDA EU representative : Obelis s.a. (Belgium) China I MDR Website sales@alltion.com EUDAMED record Report an error
Zhenjiang Excellence Medical Tech EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Biomedicinos technika Lithuania I MDR EUDAMED record Report an error
EUSA Global FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States I MDR Website EUDAMED record Report an error
Labotech Microscopes India EU representative : Labomed Europe b.v. (Netherlands) India I MDR EUDAMED record Report an error
Adamosrl Italy I MDR Website info@adamosrl.com EUDAMED record Report an error
Guangxi Visualtech S&T EU representative : Eunitor GmbH (Germany) China I MDR EUDAMED record Report an error
Atmosmed FDA Germany I MDR Website info@atmosmed.de EUDAMED record Report an error
Casio EU representative : MedNet EC-REP GmbH (Germany) Japan I MDR info_prrc1-yam@casio.co.jp EUDAMED record Report an error
Centrel Italy I MDR Website info@centrel.com EUDAMED record Report an error
Delmont imaging France I MDR Website contact@delmont-imaging.com EUDAMED record Report an error
DYSIS Medical EU representative : DYSIS MEDICAL ΕΜΠΟΡΙΑ ΙΑΤΡΙΚΟΥ ΕΞΟΠΛΙΣΜΟΥ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ (EL) United Kingdom (ex Northern Ireland) IIa MDR Website EUDAMED record Report an error
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR EUDAMED record Report an error
Gynius Sweden I MDR Website info@gynius.se EUDAMED record Report an error
Jiangsu Jinyuan Medical Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Kernelmed FDA EU representative : Caretechion GmbH (Germany) China I MDR EUDAMED record Report an error
Leisegang Germany I MDR Website EUDAMED record Report an error
Liger Medical FDA EU representative : MedNet EC-REP IIb GmbH (Germany) United States I MDR Website support@ligermedical.com EUDAMED record Report an error
Micro Instrument EU representative : CMC Medical Devices & Drugs SL (Spain) India I MDR Website info@mikoindia.com EUDAMED record Report an error
Optomic FDA Spain I MDR Website prrc@optomic.com EUDAMED record Report an error
Scaner EU representative : AFINA, spol.s r.o. (Czechia) Ukraine I MDR EUDAMED record Report an error
Softlinkmed EU representative : Eunitor GmbH (Germany) China I MDR marketing@softlinkmed.com EUDAMED record Report an error
Suzhou Sunland Medical EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Taktvoll FDA EU representative : MedPath GmbH (Germany) China I MDR Website EUDAMED record Report an error
Zumax Medical FDA EU representative : MedNet EC-REP GmbH (Germany) China I MDR sales@zumaxmedical.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) 33

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
Ecleris United States MICROSCOPE Colposcope MICROSTAR Colposcope K100595 (2010)
Coopersurgical, Inc. Present in Europe in other categories United States LEISEGANG WALLACH ColpoStar™ 1H Colposcope LEISEGANG OptiK® Model 2 Colposcope K140754 (2014)
GYNEX CORPORATION United States Galileo Colposcope, Direct Access Gynex CO Series Colposcope K061306 (2006)
ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories United States Bovie registered
HENRY SCHEIN, INC. Present in Europe in other categories United States Henry Schein registered
MedGyn Products, Inc. United States MedGyn Gynescope MedGyn Video Colposcope MedGyn Gynescope (Colposcope) K122973 (2013)
UNITED PRODUCTS & INSTRUMENTS United States UNICO ColpoMaster I UNICO ColpoMaster II UNICO ColpoMaster III K073053 (2007)
MCKESSON MEDICAL-SURGICAL INC. – McKesson registered
ILLUMIGYN LTD Israel Gynescope Image acquistion system Gynescope system, cart GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs Gynescope, console system K190187 (2019)
MEDIBLU MEDICAL LLC United States Mediblu registered
MOBILEODT LTD Israel EVA System K161871 (2016)
Waverly Life Sciences LLC United States Lutech registered
AIDOT – Cerviray registered
Carl Zeiss Meditec, AG Present in Europe in other categories United States KSK 150 FC registered
LUTECH INDUSTRIES INC Present in Europe in other categories United States Lutech K170446 (2017)
Medisono, LLC Present in Europe in other categories United States Mediblu registered
Welch Allyn, Inc. Present in Europe in other categories United States Welch Allyn, Inc. K033870 (2004)
Beijing Tech Instrument Co., Ltd. China – registered
Biop Medical , Ltd. Israel – K182764 (2018)
Bistos Co., Ltd. Present in Europe in other categories United States – registered
Borze, Inc. United States – registered
Calla Health Foundation United States – registered
Carl Zeiss Meditec AG (Jena) Present in Europe in other categories Germany – registered
ENDONEST MEDICAL SYSTEMS LLP India – registered
Hadleigh Health Technologies Present in Europe in other categories United States – K181034 (2018)
Heager GmbH Germany – registered
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED India – registered
MEDPEJ EQUIPAMENTOS MEDICOS LTDA Brazil – registered
NAS MED LLC FZ United Arab Emirates – registered
Periwinkle Technologies Pvt., Ltd. India – K233043 (2024)
Seiler Instrument & Mfg. Co., Inc. United States – registered
Shenzhen Goldcare Meditech Co., Ltd. United States – K122311 (2013)
Xuzhou AKX Electronic Science and Technology Co., Ltd Present in Europe in other categories China – registered

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