Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsOphtalmology assessments and diagnosis instruments
Ophthalmometers
EMDN code Z12120113
Manufacturers registered in Europe (EUDAMED) 11
- 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 |
|---|---|---|---|---|
| Rexxam FDA EU representative : REXXAM CZECH s.r.o. (Czechia) | Japan | I 93/42 | Website EUDAMED record Report an error | |
| Canon FDA EU representative : Canon Medical Systems Europe B.V. (Netherlands) | Japan | IIa MDR | eudamed-info@mail.canon EUDAMED record Report an error | |
| Essilor FDA | France | I MDR | Website info@essilor.fr EUDAMED record Report an error | |
| Huvitz FDA EU representative : MDSS GmbH (Germany) | South Korea | I MDR | Website EUDAMED record Report an error | |
| AkknaTek | Germany |
|
I 93/42 | info@akknatek.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 |
| Reichert FDA EU representative : Emergo Europe B.V. (Netherlands) | United States |
|
IIa 93/42 | Website EUDAMED record Report an error |
| Suowei EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIa MDR | EUDAMED record Report an error | |
| Tishyas Medical Device Development Solutions EU representative : SUNGO Europe B.V. (Netherlands) | India | I MDR | ravikiran@medevplus.com EUDAMED record Report an error | |
| View-M Technology FDA EU representative : Obelis s.a. (Belgium) | South Korea |
|
I 93/42 | Website qa1@viewmtechnology.com EUDAMED record Report an error |
| Potec FDA EU representative : MDSS GmbH (Germany) No model still on the market | South Korea | I 93/42 | Website 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) 60
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 |
|---|---|---|---|
| Nidek, Inc. Present in Europe in other categories | United States | AUTO REF/KERATOMETER AUTO REFRACTOMETER Open-field Refraction System AUTO REF/KERATO/TONOMETER HANDHELD REFRACTOMETER HANDHELD REF / KERATOMETER | K902500 (1990) |
| Topcon Corporation Present in Europe in other categories | Japan | AUTO REFRACTOMETER RM-800 AUTO KERATO-REFRACTOMETER KR-1 AUTO KERATO-REFRACTOMETER KR-800 REFRACTION SYSTEM Chronos AUTO KERATO-REFRACTOMETER KR-800PA SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM Chronos | registered |
| RIGHT MFG. CO., LTD. | Japan | Visionix | registered |
| LUNEAU TECHNOLOGY OPERATIONS | France | VISIONIX RODENSTOCK ESSILOR | registered |
| Welch Allyn, Inc. Present in Europe in other categories | United States | Welch Allyn, Inc. | registered |
| Ningbo Ming Sing Optical R & D Co., Ltd. | China | AUTO REF/KERATOMETER | registered |
| Plusoptix GmbH | Germany | plusoptiX 12 plusoptiX 16 | registered |
| Suzhou Microclear Medical Instruments Co., Ltd. Present in Europe in other categories | – | Microclear | registered |
| Tomey Corporation USA Present in Europe in other categories | United States | AUTO REFKERATOMETER AUTO REF-TOPOGRAPHER | K945959 (1995) |
| Carl Zeiss Vision GmbH Present in Europe in other categories | Germany | i.Profiler plus VISUCORE 500 Refractor | registered |
| Chongqing Yeasn Science & Technology Co.,Ltd. Present in Europe in other categories | China | YEASN | registered |
| Gobiquity, Inc. | United States | GoCheck MultiScreener GoCheck Kids | registered |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. Present in Europe in other categories | China | TIANNUO / TNMED | registered |
| SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD. Present in Europe in other categories | China | MediWorks | registered |
| U.S. OPHTHALMIC, L.L.C. | United States | Eli Ezer Gilras | registered |
| CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD Present in Europe in other categories | China | Kerato refractometer | registered |
| FORUS HEALTH PRIVATE LIMITED | – | 3nethra Ovitz Aberrometer | registered |
| REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED | India | Remidio | registered |
| Shenzhen CERTAINN Technology Co., Ltd. Present in Europe in other categories | China | MOPTIM | registered |
| Illuminix Industries LLC | – | ILLUMINIX | registered |
| Krypton Vision (Suzhou) Ltd. | – | IwavePhoropter | registered |
| Lombart Brothers, Inc. | – | S4Optik REF-K2000 | registered |
| MEDIZS Inc. | – | Medizs Auto Refractometer-Keratometer | registered |
| OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | – | Park 1 | registered |
| 123 SEE | United States | – | registered |
| APRAMED INDUSTRIA E COMERCIO DE APARELHOS MEDICOS LTDA | Brazil | – | registered |
| ATAGO CO., LTD. | Japan | – | registered |
| AUROLAB | India | – | registered |
| Adaptica Srl | Italy | – | registered |
| Baxter Healthcare Corp Present in Europe in other categories | United States | – | registered |
| Beijing Home Vision AI Tech Co.,Ltd. | China | – | registered |
| Carl Zeiss Meditec AG (Jena) Present in Europe in other categories | Germany | – | registered |
| EVERVIEW CORP | South Korea | – | registered |
| EYEQUE | United States | – | registered |
| EYEVIS MEDIWORKS PRIVATE LIMITED | India | – | registered |
| Forus Health Pvt.Ltd | India | – | registered |
| G2 OPTIC CO., LTD | South Korea | – | registered |
| GINO OPTICAL (SHANGHAI) CO., LTD. | China | – | registered |
| Greens Surgicals Private Limited | India | – | registered |
| Heru, Inc. | United States | – | registered |
| INNOVA Medical Ophthalmics Inc | Canada | – | registered |
| Jiang Xi Big Vision Medical Technology Co.,Ltd | China | – | registered |
| M/s Tarun Enterprises | India | – | registered |
| NINGBO FLO OPTICAL TECHNOLOGY DEVELOPMENT CO., LTD. | China | – | registered |
| Ovitz Corporation | United States | – | registered |
| PLENOPTIKA EUROPE SLU Present in Europe in other categories | Spain | – | registered |
| PlenOptika, Inc Present in Europe in other categories | United States | – | registered |
| Pursuant Health | United States | – | registered |
| Ray Vision Inc | United States | – | registered |
| S4OPTIK LLC | United States | – | registered |
| SHANGHAI HUVITZ Co., Ltd. Present in Europe in other categories | China | – | registered |
| SHANGHAI LINK INSTRUMENTS CO.,LTD | China | – | registered |
| Shanghai Supore Instruments Co. Ltd. Present in Europe in other categories | China | – | registered |
| Stereo Optical Co., Inc. | United States | – | K924741 (1993) |
| 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 |
| UNICOS CO., LTD. | South Korea | – | registered |
| VISIA IMAGING SRL Present in Europe in other categories | Italy | – | registered |
| WUXI ZONTAI INT'L CORPORATION LTD. | China | – | registered |
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