Instruments for functional explorations and therapeutic interventionsOphthalmology instruments
Ophtalmology assessments and diagnosis instruments
EMDN code Z121201
Manufacturers registered in Europe (EUDAMED) 154
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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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) 339
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.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Ocular Instruments, Inc. | United States | MaxLight® Triple Two Panfundus Binocular Indirect Lens (Blue) MaxField® High Mag 78 Slit Lamp Indirect Lens (Red) MaxLight® High Mag 78D Slit Lamp Indirect Lens MaxLight® 28D Binocular Indirect Lens 132D Indirect Vitrectomy Lens MaxLight® Triple Two Panfundus Binocular Indirect Lens (Red) | K935302 (1994) |
| Bernell | – | Bernell | registered |
| Amico Diagnostic Incorporated Present in Europe in other categories | United States | Amico Diagnostic Station Amico Diagnostic Wallboard Amico Diagnostic Rollstand Amico Diagnostic Ophthalmoscope Amico Diagnostic Aneroid | K131939 (2014) |
| OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | – | Pentacam AXL Wave Park 1 GONIO ready® 200 for f=200 GONIO ready® 175 for f=175 GONIO ready® CL Corvis STL | registered |
| Optego Vision USA Inc. | United States | Optego | registered |
| LUNEAU TECHNOLOGY OPERATIONS | France | VISIONIX Carl Zeiss Meditec ESSILOR RODENSTOCK ZEISS Visionix VX650 | K202221 (2021) |
| U.S. OPHTHALMIC, L.L.C. | United States | Gilras Eli Ezer LuxVision LuxVsion | K080776 (2008) |
| Rudolf Riester GmbH & Co. KG | Germany | ri-vision with slit retinoscope XL/LED 3,5V, C han ri-scope® retinoscope head slit XL 3.5 V ri-vision with retinoscope slit XL 3.5 V, C-handle ri-scope® retinoscope head slit XL 3.5 V, ri-vision with slit retinoscope XL/LED 3,5V/120V, schiötz B tonometer, inclined scale, silver | K964338 (1997) |
| Ion Vision, Inc | United States | DirectView 4 Mirror NF w/ Handle DirectView 3 Mirror NF eZView 30D DirectView 1 Mirror eZView 124 SP OmniView 85 | registered |
| COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL | – | S4 OPTIK LUMENIS IRIDEX ALCON | registered |
| Fresnel Prism & Lens Company | United States | FRESNEL PRISM AND LENS | registered |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. Present in Europe in other categories | China | TIANNUO / TNMED | registered |
| Jedmed Instrument Co. | United States | JEDMED | registered |
| FUSION ORTHOPEDICS, LLC | United States | PolyLock Small Bone Hammer Tech PolyLock Ankle DynaBridge IntraLock LapiLock | registered |
| FORUS HEALTH PRIVATE LIMITED | – | 3nethra Ovitz Aberrometer | registered |
| RIGHT MFG. CO., LTD. | Japan | Visionix | registered |
| INAMI & CO., LTD. | Japan | INAMI Inami Ophthalmic Instruments | registered |
| Interacoustics A/S Present in Europe in other categories | Denmark | Interacoustics | K200534 (2020) |
| MEDTRONIC PS MEDICAL, INC. | United States | EXTERNAL DRAINAGE MONITORING Becker | registered |
| SONTEC INSTRUMENTS, INC. | United States | HEINE MPACK UNPLUGGED BATTERY HEINE LI-ION BATTERY HEINE MPACK COMPLETE HEINE MPACK HEINE - MPACK PLUG-IN TRANSFORMER HEINE - LITHIUM ION BATTERY | registered |
| Chongqing Kanghuaruiming S&T Co., Ltd.. | China | – | K171877 (2017) |
| Phoenix Clinical | – | Phoenix ICON & FA Module with Training Kit Phoenix ICON Cart System Diffuser Phoenix ICON with Training Kit Phoenix ICON GO with Training Kit Phoenix ICON GO Control Box | registered |
| AMA Optics, Inc. | United States | AMA Optics Eye Chart AMA Optics Retinometer AMA Optics ETDRS AMA Optics Brightness Acuity Meter AMA Optics Occluder AMA Optics Lens Holder | registered |
| Med Saver, Inc. | – | MSI Precision Specialty Instruments | registered |
| OPTOS PUBLIC LIMITED COMPANY | – | Panoramic Ophthalmoscope OPTOS ADVANCE IMAGE SERVER OCT Ophthalmoscope Panoramic Opthalmoscope Optos OCT/SLO | registered |
| INVENTIS SRL Present in Europe in other categories | Italy | VNG Synapsys VHIT | K242726 (2025) |
| NEOLIGHT LLC | United States | Neolight | K223575 (2023) |
| R & D Batteries, Inc. | United States | R&D Batteries, Inc. | K942034 (1994) |
| Virtual Field, Inc. | United States | Virtual Field Carrot | registered |
| Lkc Technologies, Inc. | United States | RETeval™ | registered |
| Ningbo Ming Sing Optical R & D Co., Ltd. | China | AUTO REF/KERATOMETER LCD Chart monitor | registered |
| AMBLER SURGICAL CORP. | – | Ambler Surgical | registered |
| Virtual Vision Health | – | Virtual Eye Software Virtual Eye ELITE S Virtual Eye PRO | registered |
| Gobiquity, Inc. | United States | GoCheck MultiScreener GoCheck Kids | registered |
| INNOVA Medical Ophthalmics Inc | Canada | S4Optik Lombart | registered |
| Illuminix Industries LLC | – | ILLUMINIX | registered |
| MEDTRAK VNG, INC. | United States | MedTrakVNG MobiTrak System MobiTrakVNG Receiver MedTrakVNG Footswitch MedTrakVNG Interface Controller MedTrakVNG Goggle MobiTrak Software v3.00 | registered |
| Plusoptix GmbH | Germany | plusoptiX 12 plusoptiX 16 | registered |
| REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED | India | Remidio | K252120 (2025) |
| Trevi Technology, Inc. | – | IBEX 2-step LED slit lamp IBEX 5-step LED slit lamp IBEX Manual Refractor Applanation Tonometer IBEX Wireless LED Binocular Indirect Ophthalmoscope IBEX LCD digital acuity chart | registered |
| Accutome, Inc. | United States | AccuTip Cover Accupen | K132549 (2014) |
| Bausch & Lomb, Inc. Present in Europe in other categories | United States | Bausch + Lomb | K040913 (2004) |
| KATENA PRODUCTS, INC. | – | Primary Lens Set, 28D, 90D, 4 Mirror Primary Lens Set, 28D, 90D, 3 Mirror Glaukos SCHIOTZ TONOMETER KATENA | registered |
| VISUNEX MEDICAL SYSTEMS INC. | – | PanoCam™ LT PanoCam™ PRO PanoCam™ SOLO | registered |
| D-EYE SRL | – | D-EYE | registered |
| Identifeye Health Inc. | United States | identifeye Camera System, tablet identifeye Camera System, reconditioned identifeye Camera System, power supply identifeye Camera System | registered |
| Idmed Present in Europe in other categories | France | NL-2-DEM STA-W2 NL-2 NL-MU | registered |
| Lombart Brothers, Inc. | – | S4 Optik Advancing Eyecare S4Optik REF-K2000 Marco | registered |
| N K I | – | I-Portal Super VNG I-Portal Portable Assessment System Neuro Kinetics Inc | registered |
| Vestibular First | United States | Vestibular First | K203082 (2020) |
| DIGISIGHT TECHNOLOGIES, INC. | – | Paxos Scope | registered |
| GF HEALTH PRODUCTS, INC. Present in Europe in other categories | United States | Labtron | registered |
| Innovations Lightx Inc | – | EyeCaster | registered |
| MEDIZS Inc. | – | Medizs Digitalized Refractor DR-19 Medizs Auto Refractometer-Keratometer Medizs LED VIsual Acuity Chart LC-13 | registered |
| Micromedical Technologies, Inc. | United States | Micromedical Technologies | K964646 (1997) |
| Phelcom Technologies | Brazil | Eyer Eyer 2 Basic | K251353 (2026) |
| Spryson America, Inc. | United States | Neurolign Dx NOTC Neurolign Dx SVNG Neurolign Dx100 | registered |
| Surgical Design, Inc. | United States | ROYAL TEK | registered |
| Synapsys, Inc. | United States | Complete Monocular wireless Smart Cam system with Goggles Flex Complete Monocular wireless Smart Cam system with Xpress mask Kinetic Wi-Fi wireless VNG Ulmer system with Goggles Flex | K163558 (2017) |
| E-SWIN Present in Europe in other categories | France | TearCheck T | registered |
| Ecleris | United States | VNG 3D | registered |
| Ellex Medical Pty, Ltd. Present in Europe in other categories | Australia | Ellex | registered |
| Falck Medical, Inc. | United States | FMAT1 Prism B Falck Medical Multi-Function Applanation Tonometer | K151491 (2016) |
| INSIGHT INSTRUMENTS, INC. | – | SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT® SUPER VIEW® Disposable Wide Field Lens Set for RESIGHT® | registered |
| Krypton Vision (Suzhou) Ltd. | – | IwavePhoropter | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | MEDLINE | registered |
| Micromedical Devices, Inc. | United States | PalmScan DA2000 PalmScan VF2000 | registered |
| NEXT SIGHT SRL | Italy | NEXY PROTOZ | K180306 (2018) |
| OD-OS GmbH Present in Europe in other categories | Germany | Navilas® Laser System 577s | registered |
| OPTILASA S.L. | Spain | OPTILASA | K023676 (2003) |
| Olleyes, Inc. | United States | VisuALL VRP ETS VisuALL VRP S | registered |
| Optina Diagnostiques, Inc | – | Mydriatic Hyperspectral Retinal Camera Optina-4C | registered |
| PeriVision SA Present in Europe in other categories | Switzerland | VisionOne | registered |
| ROBERT BUSSE & CO., INC. | United States | Busse Hospital Disposables | registered |
| Retinalogik Inc. | Canada | RetinaLogik | registered |
| SIGNUS Medizintechnik GmbH | Germany | DIPLOMAT Def. | registered |
| SIS AG, Surgical Instrument Systems | United States | GALILEI | K182659 (2019) |
| SUNMED, LLC Present in Europe in other categories | United States | Sunmed | registered |
| Softcare Co., Ltd. | Japan | Laser Speckle Flowgraphy LSFG-NAVI | K153239 (2016) |
| Tearscience, Inc. Present in Europe in other categories | United States | LIPIVIEW II OCULAR SURFACE INTERFEROMETE LIPIVIEW OCULAR SURFACE INTERFEROMETER | registered |
| WESTERN SYSTEMS RESEARCH INC. | United States | ENGplus™ VAT® | K010059 (2001) |
| ZIEN MEDICAL TECHNOLOGIES, INC. | United States | CATS Tonometer CATS | registered |
| ALIMED, INC. | United States | ADSTATION OTO LED/OPH COAX LED W/SPEC | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Symmetry Allen-Schiotz | registered |
| AUTOMATED OPHTHALMICS, INC. | United States | Automated Ophthalmics Softips | K992998 (2000) |
| BERTEC CORPORATION Present in Europe in other categories | United States | Bertec Vision Advantage | registered |
| Biomet Biologics, LLC | – | Calcibon | registered |
| Bioptigen, Inc. | United States | ENFOCUS 2300 INTEGRATED OCT | K162783 (2016) |
| CLASSYS Inc. Present in Europe in other categories | South Korea | Reticapture | registered |
| CREWT MEDICAL SYSTEMS, INC. | Japan | imovifa | registered |
| Cassini Technologies B.V. | Netherlands | CASSINI | registered |
| Cellview Imaging Inc. | Canada | WRI-1 | registered |
| Changsha Airdoc Health Technology Co., Ltd. | China | Airdoc | registered |
| Chongqing Bio NewVision Medical Equipment Ltd. | China | SYSEYE | K190954 (2020) |
| EasyScan B.V. | – | EasyScan | registered |
| Fundus Photo | United States | Fundus Photo | K093071 (2010) |
| INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories | United States | Integra® Miltex® | registered |
| ISCREEN VISION, INC. | United States | iScreen Vision | K102651 (2011) |
| ISEN Tech. & Trading Co., Ltd. | China | ISEN-Goggles | K152727 (2016) |
| Ilooda Co,., Ltd. | South Korea | RetiCapture | K173474 (2018) |
The 100 most active manufacturers are shown, out of 339.
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