Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsOphtalmology assessments and diagnosis instruments
Ophtalmology assessments and diagnosis instruments - other
EMDN code Z12120199
Manufacturers registered in Europe (EUDAMED) 49
- 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.
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) 89
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) |
| 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 |
| Heidelberg Engineering GmbH Present in Europe in other categories | Germany | SPECTRALIS SPECTRALIS, HRT3, HEP SPECTRALIS, HEP | registered |
| FORUS HEALTH PRIVATE LIMITED | – | 3nethra | registered |
| OCULUS SURGICAL INC Present in Europe in other categories | United States | VERSA HD Disposable LenZ BIOM Optic Set, HD Professional, for f=200mm SUPER VIEW® Disposable Lens Set, Pivot SUPER VIEW® Disposable HD Lens Set for RESIGHT® HD Disposable, LenZ SUPER VIEW® Disposable Lens Set, Essential | registered |
| Med Saver, Inc. | – | MSI Precision Specialty Instruments | registered |
| OPTOS PUBLIC LIMITED COMPANY | – | Panoramic Ophthalmoscope OPTOS ADVANCE IMAGE SERVER OCT Ophthalmoscope Panoramic Opthalmoscope | registered |
| Welch Allyn, Inc. Present in Europe in other categories | United States | Welch Allyn, Inc. | registered |
| Phoenix Clinical | – | Phoenix Clinical ICON Control Box Phoenix Clinical ICON Phoenix Clinical White Light Module Phoenix ICON GO Phoenix Clinical ICON Cart | 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 |
| DIGISIGHT TECHNOLOGIES, INC. | – | Paxos Scope | registered |
| Heine Optotechnik GmbH & Co. KG Present in Europe in other categories | Germany | OPHTHALMOSCOPY LENS A.R. | registered |
| Innovations Lightx Inc | – | EyeCaster | registered |
| KATENA PRODUCTS, INC. | – | Primary Lens Set, 28D, 90D, 4 Mirror Primary Lens Set, 28D, 90D, 3 Mirror Glaukos | registered |
| Kowa Co. , Ltd. Present in Europe in other categories | Japan | KOWA FM-600 KOWA nonmyd AF KOWA nonmyd 8s | K091039 (2009) |
| OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | – | GONIO ready® 200 for f=200 GONIO ready® 175 for f=175 GONIO ready® CL | registered |
| REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED | India | Remidio | registered |
| INSIGHT INSTRUMENTS, INC. | – | SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT® SUPER VIEW® Disposable Wide Field Lens Set for RESIGHT® | registered |
| Phelcom Technologies | Brazil | Eyer Eyer 2 Basic | registered |
| ROBERT BUSSE & CO., INC. | United States | Busse Hospital Disposables | registered |
| Virtual Field, Inc. | United States | Carrot | registered |
| Canon, Inc. Present in Europe in other categories | United States | CANON INC. | registered |
| Cellview Imaging Inc. | Canada | WRI-1 | registered |
| Changsha Airdoc Health Technology Co., Ltd. | China | Airdoc | registered |
| EasyScan B.V. | – | EasyScan | registered |
| Haag-Streit AG Present in Europe in other categories | Switzerland | NEO 900 HS MIOS 5 | registered |
| Lombart Brothers, Inc. | – | Marco | registered |
| OD-OS GmbH Present in Europe in other categories | Germany | Navilas® Laser System 577s | registered |
| OcuSciences, Inc. | United States | OcuMet Beacon | K241931 (2025) |
| Oivi AS | Norway | Oivi Opthalmic Fundus Camera | registered |
| Optovue, Inc. Present in Europe in other categories | United States | Vivicon | registered |
| RETIVUE, LLC | United States | EntireEye Portable | registered |
| Scope Health Inc. | United States | Optase | registered |
| Spect Inc. | – | Spect Ophthalmic Camera | registered |
| U.S. OPHTHALMIC, L.L.C. | United States | Eli Ezer | registered |
| ATC Technologiess Inc. | United States | – | registered |
| Accutome, Inc. | United States | – | registered |
| All Quality & Services, Inc. | United States | – | registered |
| BIOTEQUE CORP | Taiwan | – | registered |
| Baxter Healthcare Corp Present in Europe in other categories | United States | – | registered |
| BlephEx, LLC | United States | – | registered |
| C-MER Rainsoptics Limited | Hong Kong SAR China | – | registered |
| ChongQing SS Medical Equipments Co., Ltd Present in Europe in other categories | China | – | registered |
| Chongqing Bio NewVision Medical Equipment Ltd. | China | – | registered |
| Chongqing Kanghuaruiming S&T Co., Ltd.. | China | – | registered |
| Corza Medical, Inc. | United States | – | registered |
| Elemaster SpA | Italy | – | registered |
| FABRINET CO., LTD. | Thailand | – | registered |
| FREY SPOLKA JAWNA | Poland | – | registered |
| Forus Health Pvt.Ltd | India | – | registered |
| GLAUKOS CORP. | United States | – | registered |
| Globe Biomedical | United States | – | registered |
| Hangzhou AI-MU Meditec Co., Ltd. Present in Europe in other categories | China | – | registered |
| Innokas Yhtyma Oy Present in Europe in other categories | Finland | – | registered |
| KASHMIR SURGICAL WORKS | India | – | registered |
| KYS Vision, Inc. | United States | – | registered |
| Kaynes Technology India Limited | India | – | registered |
| Kowa Company, Ltd. Chofu Factory Present in Europe in other categories | Japan | – | K261255 (2026) |
| Leadway Imaging Inc | United States | – | registered |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. Present in Europe in other categories | China | – | registered |
| Lombart Instrument, Inc. d/b/a Marco Ophthalmic | United States | – | registered |
| M/s Tarun Enterprises | India | – | registered |
| MW.FEP s.p.a. | Italy | – | registered |
| Madhu Instruments Pvt Ltd | India | – | registered |
| Main MediTech Co., Ltd | China | – | registered |
| Makromed, Inc. | United States | – | registered |
| MedNeuroptek Inc. | United States | – | registered |
| Minnetronix Medical, Inc. | United States | – | registered |
| NEOLIGHT LLC | United States | – | registered |
| Neitz Instruments Company, Ltd. Present in Europe in other categories | Japan | – | registered |
| Ningbo Ming Sing Optical R & D Co., Ltd. | China | – | registered |
| Oculus Optikgerate GmbH Present in Europe in other categories | Germany | – | registered |
| Optos Plc. Present in Europe in other categories | United States | – | K142897 (2015) |
| RUMEX INTERNATIONAL CORP. | United States | – | registered |
| Ray Vision Inc | United States | – | registered |
| Robotrak Technologies Co., Ltd. | China | – | K261740 (2026) |
| SHANGHAI LINK INSTRUMENTS CO.,LTD | China | – | registered |
| SR Research Ltd | Canada | – | registered |
| Shanghai Canton Optics Equipment Co., Ltd. | China | – | registered |
| Shenzhen Create Technology Co.,Ltd | China | – | registered |
| Shern Yeong Precise Optical Co., Ltd. | Taiwan | – | registered |
| Speedway Surgical Co. | India | – | registered |
| Suzhou 66 Vision Tech Co., Ltd. | China | – | registered |
| TAISHODO Vietnam Co., Ltd. | Vietnam | – | registered |
| TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD. | China | – | registered |
| Taiwan Main Orthopaedic Biotechnology Co., Ltd. Present in Europe in other categories | Taiwan | – | registered |
| WILD GmbH | Austria | – | registered |
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