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Emdyca

Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instrumentsInstruments for the acquisition and management of endoscopic and minimally invasive surgery images

Light sources for endoscopy and minimally invasive surgery

EMDN code Z12020402

75 manufacturers, 157 models including 156 on the market, 14 countries

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Manufacturers registered in Europe (EUDAMED) 75
  • 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
Sykers EU representative : Kingsmead Service B.V. (Netherlands) China
11 others
I MDR contact@sykers.com EUDAMED record Report an error
Sonoscape FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
7 others
I, IIa MDR ra@sonoscape.net EUDAMED record Report an error
Karlstorz FDA Germany
2 others
I, IIa MDR Website regulatory@karlstorz.com EUDAMED record Report an error
Optomedic FDA EU representative : Share info GmbH (Germany) China
1 other
I, IIa MDR Website EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I, IIa MDR Website EUDAMED record Report an error
Anhui Youtak Medical Technology EU representative : Kingsmead Service B.V. (Netherlands) China I MDR EUDAMED record Report an error
Gimmi FDA Germany I MDR Website EUDAMED record Report an error
Hikimaging EU representative : SUNGO Europe B.V. (Netherlands) China I MDR Website EUDAMED record Report an error
Olympus Winter & Ibe FDA Germany I MDR Website eudamed.regulatoryaffairs@olympus-oste.eu EUDAMED record Report an error
Shanghai Shiyin Photoelectric Instrument EU representative : Kingsmead Service B.V. (Netherlands) China I MDR EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands) China I, IIa MDR EUDAMED record Report an error
Healnoc FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China I MDR ra-registration@healnoc.com EUDAMED record Report an error
Medos International Sarl FDA EU representative : DePuy Ireland UC (Ireland) Switzerland I, IIa MDR Website EUDAMED_Enquiries@its.jnj.com EUDAMED record Report an error
Richard Wolf FDA Germany I MDR info@richard-wolf.com EUDAMED record Report an error
Shenyang Shenda Endoscope FDA EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) China I MDR Website EUDAMED record Report an error
Anhui Shiyin Photoelectric Instrument FDA EU representative : GRZAN GROUP SL (Spain) China I MDR EUDAMED record Report an error
Atmosmed FDA Germany I MDR Website info@atmosmed.de EUDAMED record Report an error
Endoso FDA EU representative : Umedwings Netherlands B.V. (Netherlands) China I MDR EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) Japan I, IIa MDR EUDAMED record Report an error
Guangzhou T.K Medical instrument FDA EU representative : MedNet EC-REP GmbH (Germany) China I MDR EUDAMED record Report an error
Jiangxi China Medical Equipment EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR Website EUDAMED record Report an error
Machida Endoscope FDA EU representative : Emergo Europe B.V. (Netherlands) Japan I MDR Website EUDAMED record Report an error
Microport FDA EU representative : MicroPort Medical B.V. (Netherlands) China I, IIa MDR Website EUDAMED record Report an error
Nanjing Tuge Healthcare EU representative : MedPath GmbH (Germany) China I MDR EUDAMED record Report an error
Olympus FDA EU representative : Olympus Europa SE & Co. KG (Germany) Japan I, IIa MDR, 93/42 EUDAMED record Report an error
PENTAX Medical FDA EU representative : PENTAX Europe GmbH (Germany) Japan IIa MDR, 93/42 Website info.emea@pentaxmedical.com EUDAMED record Report an error
Scivitamedical FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR Website info@scivitamedical.com EUDAMED record Report an error
Shantou Easywell Electronic Technologies EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Sophway FDA EU representative : Umedwings Netherlands B.V. (Netherlands) China I MDR EUDAMED record Report an error
Weyo Surgical Technology FDA EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Aesculap FDA Germany I, IIa MDR Website eudamed@bbraun.com EUDAMED record Report an error
Amnotec Germany I MDR Website EUDAMED record Report an error
Aohua EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Artrotec Spain I MDR Website info@wad-drguillen.com EUDAMED record Report an error
Beijing Fanxing Guangdian Medical Treatment Equipment FDA EU representative : Sungo Cert GmbH (Germany) China I MDR EUDAMED record Report an error
Bonss Medical Technology EU representative : Sungo Cert GmbH (Germany) China I MDR sales@plasma-surgical.com EUDAMED record Report an error
Chongqing Xishan Science & Technology EU representative : MedPath GmbH (Germany) China I MDR info@xishantech.com.cn EUDAMED record Report an error
Clearwax EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) I MDR info@clearwax.co.uk 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
Cymo Netherlands I MDR Website EUDAMED record Report an error
Eclipse Prism Medical Devices EU representative : Mars Medical (Germany) India I MDR Website info@epmdgroup.com EUDAMED record Report an error
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR EUDAMED record Report an error
Edgemed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR EUDAMED record Report an error
Endoscope-i EU representative : CERT3GLOBAL, UNIPESSOAL, LDA. (Portugal) United Kingdom (ex Northern Ireland) I MDR Website EUDAMED record Report an error
Erbe Vision FDA Germany I MDR Website info.vision.de@erbegroup.com 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
Hangzhou Hawk Optical Electronic Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR Website EUDAMED record Report an error
Hcmmed EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Hebei Boxin Recovery Equipment EU representative : SUNGO Europe B.V. (Netherlands) China I MDR info@boxinhomecare.com EUDAMED record Report an error
Ilo FDA Germany I MDR Website info@ilo.com EUDAMED record Report an error
Long Island Technology Group FDA EU representative : Obelis s.a. (Belgium) United States I MDR Website EUDAMED record Report an error
Lynmou EU representative : Umedwings Netherlands B.V. (Netherlands) China I MDR EUDAMED record Report an error
M.I.One FDA EU representative : AF Pharma Service Europe SL (Spain) South Korea I MDR info@mione.co.kr EUDAMED record Report an error
Medmicro EU representative : Umedwings Netherlands B.V. (Netherlands) China I MDR EUDAMED record Report an error
Micro Intelligent Technology (Hunan) EU representative : Everbiz GmbH (Germany) China I MDR EUDAMED record Report an error
Nanchang Woek Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Nantong Healthcare Medical Instrument EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Nopa FDA Germany I MDR Website info@nopa.de EUDAMED record Report an error
Optomic FDA Spain I MDR Website prrc@optomic.com EUDAMED record Report an error
Otopront FDA Germany I MDR Website info@otopront.de EUDAMED record Report an error
Rejoin EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR EUDAMED record Report an error
Schoelly FDA Germany I MDR Website info@schoelly.de EUDAMED record Report an error
Shanghai Oujiahua Medical Instruments EU representative : Lotus NL B.V. (Netherlands) China I MDR EUDAMED record Report an error
Shenzhen Yunze Medical Technology EU representative : Kingsmead Service B.V. (Netherlands) China I MDR EUDAMED record Report an error
STEMA Medizintechnik Germany I MDR Website info@stema-medizintechnik.de EUDAMED record Report an error
Surgical Innovations FDA EU representative : CS Life Sciences Europe Ltd (Ireland) United Kingdom (ex Northern Ireland) I MDR Website EUDAMED record Report an error
Suzhou Anying Medical Equipment EU representative : Llins Service & Consulting GmbH (Germany) China I MDR EUDAMED record Report an error
Tedansurgical FDA EU representative : TeDan Surgical Innovations B.V. (Netherlands) United States I MDR Website EUDAMED record Report an error
Tissium FDA France IIa MDR regulatory@tissium.com EUDAMED record Report an error
Tolu Sadrneshinan Pars EU representative : Glomin GmbH (Germany) Iran I MDR info@tosap.ir EUDAMED record Report an error
Unintech Germany I MDR info@unintech.de EUDAMED record Report an error
Vimex Poland I MDR Website office@vimex.eu EUDAMED record Report an error
Wuzhou Aokace Technology EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Παππας Ν. & Σια Οε Greece I MDR Website info@medical-experts.gr EUDAMED record Report an error
Suzhou Insy Medical Tecnology EU representative : GRZAN GROUP SL (Spain) No model still on the market China I 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) 160

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
Avalign Technologies, Inc. United States Millennium Avalign Pilling IMS registered
BOSS INSTRUMENTS, LTD., INC. – BOSS Instruments Stealth Surgical DB Surgical Surgical Advantage American Surgical Products registered
Geister Medizintechnik GmbH Present in Europe in other categories United States Retractor, Spinal, Speculum longitudinal Retractor, Spinal, ring-handle with double-hinge with catch Retractor, Spinal, quick-connect longitudinal with double-hinge Retractor, Spinal, ring-handle, Längs with hinge with catch Retractor, Wound, Hemilaminectomy 6x6 prongs 29cm blunt 22/42mm Retractor, Spinal, blade lateral 50mm narrow short teeth K180610 (2018)
KOROS U.S.A., INC. United States Black Belt Blunt Ti Blade Black Belt Pronged Ti Blade Black Belt Two-Level Pronged Ti Blade Black Belt Two-Level Pronged Blade Black Belt Two-Level Ti Blunt Blade Black Belt Blunt Blade K071338 (2007)
AMBLER SURGICAL CORP. – Ambler Surgical registered
STERIS Corporation Present in Europe in other categories United States Snowden-Pencer V. Mueller K100395 (2010)
Medicon eG. Chirurgiemechaniker-Genossenschaft – Medicon registered
Integra LifeSciences Corporation Present in Europe in other categories United States Integra® UltraLite® BUDDE® TEW? MAYFIELD® registered
ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories United States Symmetry Surgical Symmetry Caspar Symmetry Cloward Symmetry KARLIN™ Symmetry Mcculloch Symmetry GREENBERG® registered
Medical Illumination International Inc. United States SYSTEM TWO LED Vu VistOR MS LED MI Product Line Vistor PRO LED Vu-E K100388 (2010)
DEPUY SPINE, LLC United States SPOTLIGHT PIPELINE K062814 (2006)
SURGIX MEDICAL LLC United States Gen2 registered
TELEFLEX INCORPORATED Present in Europe in other categories United States PILLING registered
Avante – MAXX LUXX LED VISION LED VISION EX5 registered
FLEXBAR MACHINE CORPORATION United States Mediflex Fiber Optic Lightwand Davida Neurosurgery Retractor and Hand Stabilization Systems registered
NICO CORPORATION Present in Europe in other categories United States NICO Myriad NICO Myriad NOVUS NICO Myriad SPECTRA NICO BrainPath K172433 (2017)
VYCOR MEDICAL INC United States Vycor Viewsite Brain Access System Vycor Viewsite Brain Access System with Alignment Clip K202694 (2021)
MIZUHO CORPORATION Present in Europe in other categories United States SELF-RETAINING RETRACTOR registered
Micro-Tech (Nanjing) Co., Ltd. China Single-use Video Scope registered
KATALYST SURGICAL LLC United States Spetzler™ Lighted Suction Tube, 7 French, 160mm long Spetzler Lighted Suction Tube, 5 French, 140mm, Storz Conenctor Spetzler™ Lighted Suction Tube, 7 French, 120mm long Spetzler Lighted Suction Tube, 7 French 160mm, Storz Connector Spetzler™ Lighted Suction Tube, 3 French, 140mm long Spetzler™ Lighted Suction Tube, 3 French, 160mm long registered
BLACK & BLACK SURGICAL, INC. Present in Europe in other categories United States Fiberoptic Cable Headlight Cable registered
Nuvasive, Inc. Present in Europe in other categories United States MaXcess NuVasive K042034 (2004)
Adler, Inc. – Adler Instrument Company registered
NOVO SURGICAL, INC. – Novo Surgical Novo Surgical Inc. registered
Invuity, Inc. United States Invuity® Steam Sterilization Tray Breiten Sterilization Tray Synthes Fiber Optic Cable Invuity® Fiber Optic Cable Eigr™ Waveguide Invuity® Fiber Optic Sterilization Tray K113697 (2012)
Thompson Surgical Instruments, Inc. Present in Europe in other categories United States Thompson K210615 (2022)
Escalon Medical Corp. United States Fiber Optic Light Guide registered
Sopro Present in Europe in other categories France COMEG MEDICAL TECHNOLOGIES COMEG MEDICAL K103813 (2011)
SPINAL ELEMENTS, INC. United States LUCENT Lucent Lateral K082992 (2009)
ARTHREX, INC. Present in Europe in other categories United States Arthrex® registered
BR Surgical, LLC – BR Surgical, LLC registered
Conmed Corporation Present in Europe in other categories United States CONMED eLUMA registered
MAQUET GmbH Present in Europe in other categories Germany LUCEA LED ® K113679 (2012)
SANTA BARBARA IMAGING SYSTEMS, INC. Present in Europe in other categories United States OMNI Imaging (ZEOS) ZEOS registered
Boston Scientific Corp Present in Europe in other categories United States SpyGlass DS SpyGlass™ Discover registered
Ecleris United States EVERLUX LIGHT SOURCE registered
STRYKER CORPORATION Present in Europe in other categories United States LITe DECOMPRESSION Portable Red LED Light Source registered
Orthofix US LLC Present in Europe in other categories United States Orthofix Proview registered
SBI PHARMACEUTICALS CO., LTD. – Aladuck405 V220 AladuckII V100 Aladuck405 V100 AladuckII V220 registered
Surgical Direct, Inc. United States Surgical Direct registered
GULF FIBEROPTICS, INC. Present in Europe in other categories United States Surgical Headlight registered
INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories United States Integra® registered
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. United States AED Solar 2010 Portable LED Light Source AED Solar 4500 50-Watt LED Light Source AED registered
Pharaoh Neuro, Inc. United States MindsEye Expandable Port registered
Shenzhen HugeMed Medical Technical Development Co., Ltd. Present in Europe in other categories China Single-use Biliary Pancreaticobiliary Scope Image Processor registered
Visionsense, Ltd. United States VS3 Bifurcated Light Cable for MMS VS3 Iridium - Y Laser Light Cable for Fluorescence VS3 registered
Aegis Surgical, Ltd. United States Aegis Illuminated Mediastinal Access Port K160171 (2016)
Firefly Global Present in Europe in other categories United States Firefly registered
Hayden Medical, Inc. – Hayden Medical registered
SUNOPTIC TECHNOLOGIES LLC Present in Europe in other categories United States Sunoptic Technologies registered
CENTERPOINT SYSTEMS LLC United States Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps registered
FIBEROPTICS TECHNOLOGY, INC. United States Fiberoptics Technology Inc K102167 (2010)
FMD, LLC United States DUROSCOPE registered
INNO Holdings, Inc. United States TruView™ registered
MEDIMAX TECH INC. – iVision registered
Optim, LLC United States Portable Light Source K091829 (2009)
PEARSON DENTAL SUPPLIES, INC. – Vivid Max Sonic Scaler W/3 Tips registered
Rebound Therapeutics United States AURORA® Surgiscope® registered
SAPI MED SPA Present in Europe in other categories Italy Pen LED registered
Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory) Present in Europe in other categories – lmaging Processor System (lncluding Light Source) registered
Spine Wave, Inc. United States Bifurcated Retractor Illuminator registered
VITALCOR, INC United States High CRI LED Light Source registered
ZIMMER SPINE, INC. United States – K080367 (2008)
ALLIANCE PRECISION PLASTICS United States – registered
ARCH Medical Solutions - Seabrook United States – registered
ARS Co., Ltd. Japan – registered
AUGUST REUCHLEN GMBH Germany – registered
Ackermann Instrumente GmbH Present in Europe in other categories United States – registered
Anqing Changfan Medical Instrument Co., Ltd China – registered
Arch Medical Solutions United States – registered
Autocam Medical United States – registered
Avalign Delivery Systems Division United States – registered
Avalign Instruments & Implants United States – registered
Biocells Discoveries Internacional (Biocells) Ecuador – registered
Biogenomics S.A.C. - Biocells Surgical Peru – registered
Biotec Biotecnologias de Centroamerica S.A. Costa Rica – registered
Boston-Biomedical Associates United States – K170757 (2017)
Bruetsch Technology AG Switzerland – registered
Compass Intl., Inc. United States – registered
Cook, Inc. United States – registered
Cordica Medical (Formally Team Technologies, Inc) United States – registered
Crosmed S.A. Argentina – registered
Depuy Mitek, A Johnson & Johnson Company United States – registered
Dongguan MiQiang Technology Co., Ltd China – registered
ENDONEST MEDICAL SYSTEMS LLP India – registered
ENERCON TECHNOLOGIES United States – registered
Engineered Medical Systems United States – registered
FIVE STAR MANUFACTURING, INC. United States – registered
FLEXBAR MACHINE CORP., dba Mediflex United States – registered
FRIEDRICH DANIELS GMBH Germany – registered
Farmaco Quimica Nacional, S.A. Dominican Republic – registered
Fetzer Medical GmbH & Co. KG Germany – K161004 (2016)
Fetzer Surgical, LLC United States – registered
GEISTER MEDIZINTECHN Germany – registered
GLASER AG Germany – registered
GMI Corporation United States – registered
Globus Medical, Inc. Present in Europe in other categories United States – registered
HEBUMEDICAL GMBH Germany – registered
Harwood Design, Inc. United States – registered
Hermann GmbH Germany – registered

The 100 most active manufacturers are shown, out of 160.

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