Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsVarious ophtalmology instruments
Various ophtalmology instruments - consumables
EMDN code Z12129085
Manufacturers registered in Europe (EUDAMED) 4
- 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) 20
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 |
|---|---|---|---|
| Synergetics, Inc. | United States | Synergetics | K143123 (2015) |
| Peregrine Surgical , Ltd. | United States | 20GA Bipolar Pick - Universal 23GA Straight Pick - Alcon 25GA Light Pipe - Universal 20GA Bipolar Manipulator - Standard 20GA Light Pipe - 297 Connector 23GA Light Pipe - B&L | K233653 (2024) |
| Vitreq B.V. Present in Europe in other categories | Netherlands | VitreQ | registered |
| Vortex Surgical, Inc. | United States | Vortex Surgical Inc Vortex Surgical Inc. | registered |
| Nova Eye, Inc. | United States | iLumin iTrack 250A iTrack Advance iTrack 250E | K253468 (2026) |
| KATALYST SURGICAL LLC | United States | 23ga Illuminated MultiFlex™ Laser Probe, Iridex Connector 25ga Stiff MultiFlex Inverted Laser Probe, Quantel Compatible XLEND23MULTIFLEX 25ga MultiFlex Laser Probe, Iridex Compatible 23ga MultiFlex Laser Probe, Iridex Compatible XLEND25MULTIFLEX | registered |
| Alcon Laboratories, Inc. Present in Europe in other categories | United States | Alcon | K242184 (2024) |
| Bausch & Lomb, Inc. Present in Europe in other categories | United States | Bausch + Lomb | registered |
| FCI S A S FCI 20 22 | – | CHANDELIER 25G | registered |
| Lightmed Corp. Present in Europe in other categories | Taiwan | Cyclophotocoagulation Probe | registered |
| MEDIMAX TECH INC. | – | iChopper | registered |
| Carl Zeiss Meditec AG (Jena) Present in Europe in other categories | Germany | – | registered |
| D.O.R.C. Dutch Ophthalmic Research Center (International) B. | Netherlands | – | registered |
| HARMAC MEDICAL PRODUCTS, INC. | United States | – | registered |
| Iridex Corp Present in Europe in other categories | United States | – | registered |
| Medical Wholsale Suplies, Inc, | Canada | – | registered |
| Nova Eye Inc. (Business Name Nova Eye Medical) | United States | – | K221872 (2023) |
| Nova Eye Medical Ltd | Australia | – | registered |
| Oculight , Ltd. | South Korea | – | K202670 (2021) |
| SHINA CORP. | South Korea | – | registered |
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