Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsOphtalmology assessments and diagnosis instruments
Ophtalmology assessments and diagnosis instruments - hardware accessories
EMDN code Z12120180
Manufacturers registered in Europe (EUDAMED) 10
- 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) 38
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 |
|---|---|---|---|
| Bernell | – | Bernell | registered |
| Optego Vision USA Inc. | United States | Optego | registered |
| Fresnel Prism & Lens Company | United States | FRESNEL PRISM AND LENS | registered |
| OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | – | BK S2, without convex cylinders, coated, wooden case with handle BK S1/T without convex cylinders, table version, trial lens case Prism Lens Case S, coated BK S1/W, wall version, trial lens case BK S1/W, without convex cylinders, coated, wall version, trial lens case BK S2 B, without convex cylinders, wooden case with handle | registered |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. Present in Europe in other categories | China | TIANNUO / TNMED | registered |
| AMA Optics, Inc. | United States | AMA Optics Occluder AMA Optics Lens Holder | registered |
| REXXAM CO., LTD. Present in Europe in other categories | Japan | Rexxam | registered |
| REICHERT, INC. Present in Europe in other categories | United States | TS75 Trial Lens | registered |
| Akriti Ophthalmic Private Limited | India | – | registered |
| Apothecaries Sundries Mfg Pvt Ltd | India | – | registered |
| CHARMANT INC. | Japan | – | registered |
| Danyang New Hope Medical Equipment Co., Ltd Present in Europe in other categories | China | – | registered |
| EPSILON EYE CARE PVT., LTD. | India | – | registered |
| GINO OPTICAL (SHANGHAI) CO., LTD. | China | – | registered |
| Greens Surgicals Private Limited | India | – | registered |
| H. Ogino & Co., Ltd. | Japan | – | registered |
| IKETANI Co., Ltd. | Japan | – | registered |
| INAMI & CO., LTD. | Japan | – | registered |
| Indo-German Surgical Corporation | India | – | registered |
| Jiangsu Liangxu Intelligence Science and Technology Co., Ltd | China | – | registered |
| KDANS SURGICAL PRIVATE LIMITED | India | – | registered |
| LangFang Far East Prosperous Optical Instrument Co.,Ltd. Present in Europe in other categories | China | – | registered |
| M/s Tarun Enterprises | India | – | registered |
| NARANG MEDICAL, LTD. Present in Europe in other categories | India | – | registered |
| OPTICA FUKUI, INC. | Japan | – | registered |
| PAUL INSTRUMENTS (INDIA) | United States | – | registered |
| Polette Limited | Hong Kong SAR China | – | registered |
| Ray Vision Inc | United States | – | registered |
| SHANGHAI LINK INSTRUMENTS CO.,LTD | China | – | registered |
| Shanghai Canton Optics Equipment Co., Ltd. | China | – | registered |
| Speedway Surgical Co. | India | – | registered |
| TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD. | China | – | registered |
| TOPCON HEALTHCARE INC Present in Europe in other categories | United States | – | registered |
| Taiyuan North China Xinyuan Tech. Center (Co., LTD.) Present in Europe in other categories | China | – | registered |
| Towa Medical Instruments Co.,Ltd | Japan | – | registered |
| Update Optical Manufacturer Limited | China | – | registered |
| WUXI ZONTAI INT'L CORPORATION LTD. | China | – | registered |
| Wenzhou Hala Trade Co.Ltd | China | – | registered |
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