Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsOphtalmology assessments and diagnosis instruments
Retinoscopes
EMDN code Z12120118
Manufacturers registered in Europe (EUDAMED) 7
- 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 |
|---|---|---|---|---|
| Neitz FDA EU representative : MDSS GmbH (Germany) | Japan | I MDR | Website EUDAMED record Report an error | |
| Heine FDA | Germany | I MDR | Website info@heine.com EUDAMED record Report an error | |
| 66Vision EU representative : Wellkang Ltd (Northern Ireland) | China | I MDR | EUDAMED record Report an error | |
| Keeler FDA EU representative : Keeler Europe Distribution, S.L. (Spain) | United Kingdom (ex Northern Ireland) | I MDR | Website regulatory@keeler.co.uk EUDAMED record Report an error | |
| Suzhou Kangjie Medical FDA EU representative : Kingsmead Service B.V. (Netherlands) | China | I MDR | EUDAMED record Report an error | |
| Welch Allyn FDA EU representative : Welch Allyn Limited (Ireland) | United States |
|
I MDR | Website EUDAMED record Report an error |
| Zumax Medical FDA EU representative : MedNet EC-REP GmbH (Germany) | China |
|
I MDR | sales@zumaxmedical.com 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) 21
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 |
|---|---|---|---|
| Rudolf Riester GmbH & Co. KG | Germany | ri-vision with slit retinoscope XL/LED 3,5V, C han ri-scope® retinoscope head slit XL 3.5 V ri-vision with retinoscope slit XL 3.5 V, C-handle ri-scope® retinoscope head slit XL 3.5 V, ri-vision with slit retinoscope XL/LED 3,5V/120V, | K964338 (1997) |
| U.S. OPHTHALMIC, L.L.C. | United States | Eli Ezer | registered |
| REICHERT, INC. Present in Europe in other categories | United States | OptochekPlus | registered |
| Apothecaries Sundries Mfg Pvt Ltd | India | – | registered |
| Baxter Healthcare Corp Present in Europe in other categories | United States | – | registered |
| Greens Surgicals Private Limited | India | – | registered |
| KASHMIR SURGICAL WORKS | India | – | registered |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. Present in Europe in other categories | China | – | registered |
| M/s Tarun Enterprises | India | – | registered |
| MEDI.PLAN GmbH & Co. KG | Germany | – | registered |
| Ray Vision Inc | United States | – | registered |
| Shanghai Supore Instruments Co. Ltd. Present in Europe in other categories | China | – | registered |
| Suzhou 66 Vision Tech Co., Ltd. | China | – | 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 |
| VEENAK INTERNATIONAL LIMITED | United Kingdom | – | registered |
| VISION RESEARCH CORP. | United States | – | registered |
| VISION TRAINING PRODUCTS, INC. | United States | – | registered |
| WUXI ZONTAI INT'L CORPORATION LTD. | China | – | registered |
| Worldwide Supplies Limited | Hong Kong SAR China | – | registered |
| Xenon Ophthalmics Inc | United States | – | registered |
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