Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsOphtalmology assessments and diagnosis instruments
Optometers
EMDN code Z12120115
Manufacturers registered in Europe (EUDAMED) 13
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Super Vision Optical Tech EU representative : BioDomi GmbH (Germany) | China | IIa MDR | EUDAMED record Report an error | |
| Topcon FDA EU representative : Topcon Europe Medical BV (Netherlands) | Japan | I MDR, 93/42 | 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 93/42 | Website ramesh.jagadeesan@appasamy.com EUDAMED record Report an error | |
| General ASDE | Spain | I MDR | Website EUDAMED record Report an error | |
| Nidek FDA EU representative : NIDEK SA (France) | Japan | I MDR | EUDAMED record Report an error | |
| Plenoptika FDA | Spain | IIa MDR | Website support@plenoptika.com EUDAMED record Report an error | |
| Reichert FDA EU representative : Emergo Europe B.V. (Netherlands) | United States | I MDR | Website EUDAMED record Report an error | |
| Huvitz FDA EU representative : MDSS GmbH (Germany) | South Korea | I MDR | Website EUDAMED record Report an error | |
| Potec FDA EU representative : MDSS GmbH (Germany) | South Korea | I MDR | Website EUDAMED record Report an error | |
| Rexxam FDA EU representative : Rexxam Co., Ltd. Netherlands Office (Netherlands) | Japan |
|
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 | |
| Thondar EU representative : SUNGO Europe B.V. (Netherlands) | China | I MDR | 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) 43
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 |
|---|---|---|---|
| INNOVA Medical Ophthalmics Inc | Canada | S4Optik Lombart | registered |
| ESSILOR INTERNATIONAL Present in Europe in other categories | United States | Vision-R 700 Vision-R 800 Vision-S 700 | registered |
| Shenzhen CERTAINN Technology Co., Ltd. Present in Europe in other categories | China | MOPTIM | registered |
| U.S. OPHTHALMIC, L.L.C. | United States | Eli Ezer Gilras LuxVsion | registered |
| LUNEAU TECHNOLOGY OPERATIONS | France | VISIONIX | registered |
| Lombart Brothers, Inc. | – | S4 Optik Advancing Eyecare | registered |
| FORUS HEALTH PRIVATE LIMITED | – | 3nethra | registered |
| Illuminix Industries LLC | – | ILLUMINIX | registered |
| Krypton Vision (Suzhou) Ltd. | – | IwavePhoropter | registered |
| MEDIZS Inc. | – | Medizs Digitalized Refractor DR-19 | registered |
| TAKAGI SEIKO CO.,LTD. Present in Europe in other categories | Japan | TAKAGI | registered |
| Trevi Technology, Inc. | – | IBEX Manual Refractor | registered |
| APRAMED INDUSTRIA E COMERCIO DE APARELHOS MEDICOS LTDA | Brazil | – | registered |
| Adaptica Srl | Italy | – | registered |
| Apramed USA LLC | United States | – | registered |
| Blue.S4 | Canada | – | registered |
| Carl Zeiss Vision GmbH Present in Europe in other categories | Germany | – | registered |
| Danyang New Hope Medical Equipment Co., Ltd Present in Europe in other categories | China | – | registered |
| EVERVIEW CORP | South Korea | – | registered |
| EYEQUE | United States | – | registered |
| Forus Health Pvt.Ltd | India | – | registered |
| GINO OPTICAL (SHANGHAI) CO., LTD. | China | – | registered |
| H. Ogino & Co., Ltd. | Japan | – | registered |
| Haag-Streit AG Present in Europe in other categories | Switzerland | – | registered |
| INAMI & CO., LTD. | Japan | – | registered |
| KEELER LIMITED Present in Europe in other categories | United States | – | registered |
| LangFang Far East Prosperous Optical Instrument Co.,Ltd. Present in Europe in other categories | China | – | registered |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. Present in Europe in other categories | China | – | registered |
| Lombart Instrument, Inc d/b/a Advancing Eyecare | United States | – | registered |
| NINGBO FLO OPTICAL TECHNOLOGY DEVELOPMENT CO., LTD. | China | – | registered |
| Ningbo Ming Sing Optical R & D Co., Ltd. | China | – | registered |
| Ray Vision Inc | United States | – | registered |
| S4OPTIK LLC | United States | – | registered |
| SHANGHAI LINK INSTRUMENTS CO.,LTD | China | – | registered |
| Shanghai Canton Optics Equipment Co., Ltd. | China | – | registered |
| SiVIEW SAS Present in Europe in other categories | France | – | registered |
| TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD. | China | – | registered |
| Taiyuan North China Xinyuan Tech. Center (Co., LTD.) Present in Europe in other categories | China | – | registered |
| Towa Medical Instruments Co.,Ltd | Japan | – | registered |
| UNICOS CO., LTD. | South Korea | – | registered |
| VIEW-M TECHNOLOGY CO., LTD. Present in Europe in other categories | South Korea | – | registered |
| Vmax Vision Inc. | United States | – | registered |
| WUXI ZONTAI INT'L CORPORATION LTD. | China | – | registered |
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