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Emdyca

Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsVarious ophtalmology instruments

Various ophtalmology instruments - consumables

EMDN code Z12129085

4 manufacturers, 36 models including 36 on the market, 4 countries

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Manufacturers registered in Europe (EUDAMED) 4
  • 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
D.O.R.C. Dutch Ophthalmic Research Center (International) FDA Netherlands
28 others
IIa 93/42 Website EUDAMED record Report an error
Fabrinal FDA EU representative : Veranex Germany GmbH (Germany) Switzerland IIa MDR Website info@fabrinal.ch EUDAMED record Report an error
France Chirurgie Instrumentation FDA France IIa MDR Website EUDAMED record Report an error
Gaush FDA EU representative : MedPath GmbH (Germany) 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) 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
Synergetics, Inc. United States Synergetics K143123 (2015)
Peregrine Surgical , Ltd. United States 20GA Bipolar Pick - Universal 23GA Straight Pick - Alcon 25GA Light Pipe - Universal 20GA Bipolar Manipulator - Standard 20GA Light Pipe - 297 Connector 23GA Light Pipe - B&L K233653 (2024)
Vitreq B.V. Present in Europe in other categories Netherlands VitreQ registered
Vortex Surgical, Inc. United States Vortex Surgical Inc Vortex Surgical Inc. registered
Nova Eye, Inc. United States iLumin iTrack 250A iTrack Advance iTrack 250E K253468 (2026)
KATALYST SURGICAL LLC United States 23ga Illuminated MultiFlex™ Laser Probe, Iridex Connector 25ga Stiff MultiFlex Inverted Laser Probe, Quantel Compatible XLEND23MULTIFLEX 25ga MultiFlex Laser Probe, Iridex Compatible 23ga MultiFlex Laser Probe, Iridex Compatible XLEND25MULTIFLEX registered
Alcon Laboratories, Inc. Present in Europe in other categories United States Alcon K242184 (2024)
Bausch & Lomb, Inc. Present in Europe in other categories United States Bausch + Lomb registered
FCI S A S FCI 20 22 – CHANDELIER 25G registered
Lightmed Corp. Present in Europe in other categories Taiwan Cyclophotocoagulation Probe registered
MEDIMAX TECH INC. – iChopper registered
Carl Zeiss Meditec AG (Jena) Present in Europe in other categories Germany – registered
D.O.R.C. Dutch Ophthalmic Research Center (International) B. Netherlands – registered
HARMAC MEDICAL PRODUCTS, INC. United States – registered
Iridex Corp Present in Europe in other categories United States – registered
Medical Wholsale Suplies, Inc, Canada – registered
Nova Eye Inc. (Business Name Nova Eye Medical) United States – K221872 (2023)
Nova Eye Medical Ltd Australia – registered
Oculight , Ltd. South Korea – K202670 (2021)
SHINA CORP. South Korea – registered

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