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Emdyca

Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsOphtalmology assessments and diagnosis instruments

Instruments for the assessment of visual functionality

EMDN code Z12120120

42 manufacturers, 96 models including 91 on the market, 16 countries

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Manufacturers registered in Europe (EUDAMED) 42
  • 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
Diagnosysllc FDA EU representative : Diagnosys Vision Limited (Ireland) United States
6 others
IIa 93/42 Website mail@diagnosysllc.com EUDAMED record Report an error
Oculus FDA Germany
4 others
I MDR Website sales@oculus.de EUDAMED record Report an error
Ortho Km Sweden
4 others
I MDR Website info@syntavlor.se EUDAMED record Report an error
FIM Medical FDA France I MDR Website contact@fim-medical.com EUDAMED record Report an error
Centervue FDA Italy IIa MDR, 93/42 Website info@icare-world.com EUDAMED record Report an error
Zeiss FDA EU representative : Carl Zeiss Meditec AG (Germany) Germany, United States I, IIa MDR, 93/42 Website EUDAMED record Report an error
Essilor FDA France I MDR Website info@essilor.fr EUDAMED record Report an error
Haag-Streit FDA EU representative : Haag-Streit Deutschland GmbH (Germany) Switzerland IIa MDR, 93/42 Website regulatory@haag-streit.com EUDAMED record Report an error
Optopol FDA Poland I MDR Website info@optopol.com.pl EUDAMED record Report an error
Taiyuan North China Xinyuan Tech Center FDA EU representative : MedPath GmbH (Germany) China I MDR EUDAMED record Report an error
Topcon FDA EU representative : Topcon Europe Medical BV (Netherlands) Japan I MDR Website EUDAMED record Report an error
ChongQing SunKingdom Medical Instrument FDA EU representative : MedNet EC-REP GmbH (Germany) China I MDR Website sales@cqsunkingdom.com EUDAMED record Report an error
Gaush FDA EU representative : Luxus Lebenswelt GmbH (Germany) China I MDR EUDAMED record Report an error
Huvitz FDA EU representative : MDSS GmbH (Germany) South Korea I MDR Website EUDAMED record Report an error
Mediworks FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China I, IIa MDR Website EUDAMED record Report an error
Potec FDA EU representative : MDSS GmbH (Germany) South Korea I MDR Website EUDAMED record Report an error
Precision Vision FDA EU representative : QNET B.V. (Netherlands) United States I MDR Website EUDAMED record Report an error
Shanghai Huvitz FDA EU representative : LGMed Trades Oy (Finland) China I MDR Website EUDAMED record Report an error
Yeasn FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China I MDR sale@yeasn.com EUDAMED record Report an error
Appasamy FDA EU representative : Amstermed B.V. (Netherlands) India I MDR ramesh.jagadeesan@appasamy.com EUDAMED record Report an error
Deutsche Augenoptik Germany I MDR Website EUDAMED record Report an error
Evans (Instruments) EU representative : VeriSafe Compliance Limited (Ireland) United Kingdom (ex Northern Ireland) I MDR Website sales@evansinstruments.co.uk EUDAMED record Report an error
EVEX Deutschland Germany I MDR Website info@ipro.de EUDAMED record Report an error
Findex EU representative : Rexxam Co., Ltd. Netherlands Office (Netherlands) Japan I MDR EUDAMED record Report an error
General ASDE Spain I MDR Website EUDAMED record Report an error
Gulden Ophthalmics FDA EU representative : QbD RepS BV (Belgium) United States I MDR Website info@guldenophthalmics.com EUDAMED record Report an error
Konanmedical FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) United States IIa MDR Website EUDAMED record Report an error
Kowa FDA EU representative : Kowa Medical Care Europe GmbH (Germany) Japan I MDR EUDAMED record Report an error
Meden Poland I MDR Website eudamed@meden.com.pl EUDAMED record Report an error
Medical Manufacturers Pty EU representative : Advena Limited (Malta) Australia I MDR Website quality@ingeneus.com.au EUDAMED record Report an error
Mnm Ingenieria Sca Spain I 93/42 EUDAMED record Report an error
NEXACorteX s.r.o Czechia I MDR Website info@optosense.cz EUDAMED record Report an error
Reichert FDA EU representative : Emergo Europe B.V. (Netherlands) United States I MDR Website EUDAMED record Report an error
Reyedar Netherlands I MDR Website info@reyedar.com EUDAMED record Report an error
Suowei EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Thomson Software Solutions EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) I MDR Website EUDAMED record Report an error
Visia imaging FDA Italy I MDR quality.hcs.it@topcon.com EUDAMED record Report an error
Vision Assessment EU representative : MDSS GmbH (Germany) United States I MDR Website sales@VisionAssessment.com EUDAMED record Report an error
Vistec Germany I MDR Website info@vistec-ag.de EUDAMED record Report an error
Waggoner Diagnostics EU representative : E C REP LIMITED (Ireland) United States I MDR Website EUDAMED record Report an error
Dive Medical No model still on the market Spain IIa MDR Website info@dive-medical.com EUDAMED record Report an error
Effectum Medical No model still on the market Switzerland IIa MDR Website info@effectummedical.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) 128

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
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung – Twinfield 3 Centerfield 2 Twinfield 2 Smartfield Easyfield S Easyfield C registered
VIEW-M TECHNOLOGY CO., LTD. Present in Europe in other categories South Korea Visual Chart System Self Vision Tester LCD ACUITY DEVICE registered
AMA Optics, Inc. United States AMA Optics Eye Chart AMA Optics Retinometer AMA Optics ETDRS AMA Optics Brightness Acuity Meter registered
Nidek, Inc. Present in Europe in other categories United States CHART PROJECTOR Open-field Refraction System SYSTEM CHART Tabletop Refraction System SPACE SAVING CHART MICROPERIMETER registered
Chongqing Kanghuaruiming S&T Co., Ltd.. China – registered
Virtual Field, Inc. United States Virtual Field Carrot registered
Virtual Vision Health – Virtual Eye Software Virtual Eye ELITE S Virtual Eye PRO registered
LUNEAU TECHNOLOGY OPERATIONS France Visionix registered
METROVISION Present in Europe in other categories France Vision Monitor - MonPackONE Vision Monitor - MonCv3 Vision Monitor - MonColor Vision Monitor - MonCvONE registered
Heine Optotechnik GmbH & Co. KG Present in Europe in other categories Germany LAMBDA 100 registered
ChongQing SS Medical Equipments Co., Ltd Present in Europe in other categories China SYL S4OPTIK registered
Gobiquity, Inc. United States GoCheck MultiScreener GoCheck Kids registered
MEDMONT INTERNATIONAL PTY LTD Present in Europe in other categories Australia Visual Function Tester AT20P Medmont Automated Perimeter DAC Medmont Automated Perimeter M700 USB registered
Optego Vision USA Inc. United States Optego registered
U.S. OPHTHALMIC, L.L.C. United States Eli Ezer registered
Alcon Laboratories, Inc. Present in Europe in other categories United States Alcon registered
Heidelberg Engineering GmbH Present in Europe in other categories Germany SPECTRALIS, HEP SPECTRALIS, HRT3, HEP registered
INAMI & CO., LTD. Japan Inami Ophthalmic Instruments INAMI registered
Micromedical Devices, Inc. United States PalmScan DA2000 PalmScan VF2000 registered
Ningbo Ming Sing Optical R & D Co., Ltd. China LCD Chart monitor registered
Olleyes, Inc. United States VisuALL VRP ETS VisuALL VRP S registered
PeriVision SA Present in Europe in other categories Switzerland VisionOne registered
REXXAM CO., LTD. Present in Europe in other categories Japan Rexxam registered
Retinalogik Inc. Canada RetinaLogik registered
TAKAGI SEIKO CO.,LTD. Present in Europe in other categories Japan TAKAGI MARCO registered
BERTEC CORPORATION Present in Europe in other categories United States Bertec Vision Advantage registered
CREWT MEDICAL SYSTEMS, INC. Japan imovifa registered
Illuminix Industries LLC – ILLUMINIX registered
KONAN MEDICAL USA, INC. Present in Europe in other categories Japan – registered
MEDIZS Inc. – Medizs LED VIsual Acuity Chart LC-13 registered
Med Saver, Inc. – MSI Precision Specialty Instruments registered
NOTAL VISION LTD United States Foresee Home™ K091579 (2009)
Nidek Technologies Srl Present in Europe in other categories Italy MP-1S registered
Novavision, Inc. Present in Europe in other categories United States Vision Restoration Therapy K023623 (2003)
RadiusXR, Inc. United States Radius Inspire registered
Trevi Technology, Inc. – IBEX LCD digital acuity chart registered
1800 CONTACTS, INC United States – registered
6 OVER 6 VISION LTD Israel – registered
APRAMED INDUSTRIA E COMERCIO DE APARELHOS MEDICOS LTDA Brazil – registered
ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories United States – registered
AUROLAB India – registered
Acuity Pro, Inc. United States – registered
Adaptive Sensory Technology Inc United States – registered
Akriti Ophthalmic Private Limited India – registered
Apothecaries Sundries Mfg Pvt Ltd India – registered
Apramed USA LLC United States – registered
CHARMANT INC. Japan – registered
DU-HOPE INTERNATIONAL GROUP China – registered
Danyang New Hope Medical Equipment Co., Ltd Present in Europe in other categories China – registered
EPSILON EYE CARE PVT., LTD. India – registered
EVO DI BRIDDA MASSIMO Italy – registered
EYEQUE United States – registered
EYEVIS MEDIWORKS PRIVATE LIMITED India – registered
Elemaster SpA Italy – registered
Elevate Solutions Group, LLC United States – registered
Eyeonic Pty Limited Australia – registered
FREY SPOLKA JAWNA Poland – registered
FUJIFILM Manufacturing Corp. Japan – registered
G2 OPTIC CO., LTD South Korea – registered
GINO OPTICAL (SHANGHAI) CO., LTD. China – registered
GST CORPORATION LIMITED Present in Europe in other categories India – registered
Gome Optical Lens Company Limited United States – registered
Good-Lite Co. United States – K833956 (1984)
Greens Surgicals Private Limited India – registered
H. Ogino & Co., Ltd. Japan – registered
HUA YI MANUFACTORY China – registered
Harvest Digital LLC United States – registered
Heru, Inc. United States – registered
INNOVA Medical Ophthalmics Inc Canada – registered
ISCON SURGICALS, LTD. India – registered
Indo-German Surgical Corporation India – registered
JALTEK SYSTEMS LIMITED United Kingdom – registered
Jiangsu Liangxu Intelligence Science and Technology Co., Ltd China – registered
Jiangyin Huaying Light Industrial Products Co., LTD China – registered
KASHMIR SURGICAL WORKS India – registered
KDANS SURGICAL PRIVATE LIMITED India – registered
KEELER LIMITED Present in Europe in other categories United States – registered
KYS Vision, Inc. United States – registered
LINDBERG A/S Denmark – registered
Lombart Instrument, Inc. d/b/a Marco Ophthalmic United States – registered
M/s Tarun Enterprises India – registered
MDF Instruments Medifriend Inc. Present in Europe in other categories China – registered
MW.FEP s.p.a. Italy – registered
Main MediTech Co., Ltd China – registered
Makromed, Inc. United States – registered
MedNeuroptek Inc. United States – registered
Miller Technical Services United States – registered
Mirazo Co.,Ltd. Thailand – registered
Morgan Newton Company United States – registered
NARANG MEDICAL, LTD. Present in Europe in other categories India – registered
NINGBO FLO OPTICAL TECHNOLOGY DEVELOPMENT CO., LTD. China – registered
OPTICA FUKUI, INC. Japan – registered
Oculera Saglik Teknolojileri A.S. Türkiye – registered
PAUL INSTRUMENTS (INDIA) United States – registered
PRECISION TECHNOLOGY SERVICES, LTD. Canada – registered
PerZeption Inc. United States – registered
Peripherex Inc. United States – registered
Polette Limited Hong Kong SAR China – registered
Pursuant Health United States – registered
READY SET IMPORT dba Mynt Professional United States – registered

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