Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsOphtalmology assessments and diagnosis instruments
Ophthalmoscopes
EMDN code Z12120114
Manufacturers registered in Europe (EUDAMED) 37
- 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) 68
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 |
|---|---|---|---|
| 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) |
| Optovue, Inc. Present in Europe in other categories | United States | iVue RTVue XR Avanti iScan RTVue XR Avanti Scanner Avanti iStand | K153080 (2016) |
| Rudolf Riester GmbH & Co. KG | Germany | e-scope® F.O. otoscope / ophthalmoscope LED 3.7 V, Wall diagnostic ri-former® 1 handle 3.5 V / 120 V without clock e-scope® F.O. otoscope / ophthalmoscope XL 2.5 V, Wall diagnostic ri-former® 1 handle 3.5 V / 230 V without clock Wall diagnostic ri-former® 1 handle 3.5 V / 230 V with clock econom® Vac. 2.7 V / XL 2.5 V, C-handle | K950914 (1995) |
| 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 |
| R & D Batteries, Inc. | United States | R&D Batteries, Inc. | K942034 (1994) |
| U.S. OPHTHALMIC, L.L.C. | United States | Eli Ezer | registered |
| GF HEALTH PRODUCTS, INC. Present in Europe in other categories | United States | Labtron | registered |
| Jedmed Instrument Co. | United States | JEDMED | registered |
| Surgical Design, Inc. | United States | ROYAL TEK | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | MEDLINE | registered |
| SUNMED, LLC Present in Europe in other categories | United States | Sunmed | registered |
| Softcare Co., Ltd. | Japan | Laser Speckle Flowgraphy LSFG-NAVI | registered |
| ALIMED, INC. | United States | ADSTATION OTO LED/OPH COAX LED W/SPEC | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| OPTOS PUBLIC LIMITED COMPANY | – | Panoramic Ophthalmoscope | registered |
| Robotrak Technologies Co., Ltd. | China | Robotrak | registered |
| Trevi Technology, Inc. | – | IBEX Wireless LED Binocular Indirect Ophthalmoscope | registered |
| Armatech International | Pakistan | – | registered |
| B. Ali Impex | Pakistan | – | registered |
| Baxter Healthcare Corp Present in Europe in other categories | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CRYSTALVUE MEDICAL CORPORATION Present in Europe in other categories | Taiwan | – | registered |
| Carl Zeiss Meditec AG (Jena) Present in Europe in other categories | Germany | – | registered |
| Crown Surgical Corp. | Pakistan | – | registered |
| Doctor Devices | Pakistan | – | registered |
| Foshan Any Home Care Medical Technology Co.,Ltd. Present in Europe in other categories | China | – | registered |
| GULMAG INTERNATIONAL | Pakistan | – | registered |
| Greens Surgicals Private Limited | India | – | registered |
| HILBRO INTERNATIONAL (PVT) LIMITED Present in Europe in other categories | Pakistan | – | registered |
| Hai Laboratories, Inc. | United States | – | K994340 (2000) |
| Hazel Enterprises | Pakistan | – | registered |
| Hexamed Pvt Ltd | Pakistan | – | registered |
| Imperial Trading Limited | Barbados | – | registered |
| Innopex Limited | Canada | – | registered |
| Jiang Xi Big Vision Medical Technology Co.,Ltd | China | – | registered |
| KASHMIR SURGICAL WORKS | India | – | registered |
| Little Doctor Electronic (Nantong)Co.,Ltd | China | – | registered |
| Long Life Surgical Industries Present in Europe in other categories | Pakistan | – | registered |
| M/s Tarun Enterprises | India | – | registered |
| MADINA SURGICAL WORKS | Pakistan | – | registered |
| MARKEN HEALTHTECH LIMITED | India | – | registered |
| MED2B LTD. | Germany | – | registered |
| MEDI.PLAN GmbH & Co. KG | Germany | – | registered |
| MW.FEP s.p.a. | Italy | – | registered |
| Mainline Medical Dental Supply | Canada | – | registered |
| Mark Enterprises | India | – | registered |
| Medcave Private Limited | Pakistan | – | registered |
| Medical Devices (Pvt) , Ltd. | Pakistan | – | K131719 (2013) |
| ORTA MEDICAL LTD | Israel | – | registered |
| PALM MEDICAL INTERNATIONAL BV | Belgium | – | registered |
| PHARMCO MEDICAL BV | Netherlands | – | registered |
| Ray Vision Inc | United States | – | registered |
| SAHIROUN (PVT) LTD. | Pakistan | – | registered |
| SHANGHAI LINK INSTRUMENTS CO.,LTD | China | – | registered |
| ST ANDREWS MEDICAL INNOVATIONS LIMITED | United Kingdom | – | registered |
| SUZHOU RAISH MEDITECH CO., LTD | China | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Shanghai Canton Optics Equipment Co., Ltd. | China | – | registered |
| Speedway Surgical Co. | India | – | registered |
| Suzhou 66 Vision Tech Co., Ltd. | China | – | K052599 (2006) |
| Swengg Co | Pakistan | – | registered |
| TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD. | China | – | registered |
| Taihu Huamei Medical Equipment Co.,Ltd | China | – | registered |
| VEENAK INTERNATIONAL LIMITED | United Kingdom | – | registered |
| VITAL AIR FZCO | United Arab Emirates | – | registered |
| WASHINGTON SURGICAL INTERNATIONAL | Pakistan | – | registered |
| WUXI ZONTAI INT'L CORPORATION LTD. | China | – | registered |
| Worldwide Supplies Limited | Hong Kong SAR China | – | registered |
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