Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsTherapeutic and surgical ophtholmological treatments instruments
Phaco-vitrectomy instruments
EMDN code Z12120207
Manufacturers registered in Europe (EUDAMED) 9
- 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) 66
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 |
|---|---|---|---|
| Microsurgical Technology, Inc. | United States | MST/Packard A1 .7mm Phaco Tip Bent Dewey 30° MST .7mm A1 Bent Phaco Tip 45° MST/Packard A1 .7mm Phaco Tip Bent Dewey 45° MST/Packard A1 .7mm 12° Bend Phaco Tip, Reverse Bevel MST/Packard .7mm Bent Phaco Tip 30° MST/Packard A1 .7mm 12° Bend Phaco Tip Dewey 45° | K953959 (1995) |
| Bausch & Lomb, Inc. Present in Europe in other categories | United States | Bausch + Lomb Stellaris Millennium MICS SIL I/A HDP 45° STELL 1/B SILICONE I/A HANDP CURVED 1/B IRR HANDPIECE SMOOTH,20G,12/BX | K261264 (2026) |
| Medical Instrument Development Laboratories, Inc. | United States | Bi-Blade® Bi-Blade™ Adaptable Vit Enhancer™ Ultimate Vit Enhancer™ | K153168 (2016) |
| Oertli Instrumente AG Present in Europe in other categories | Switzerland | Oertli® | K233398 (2024) |
| Synergetics, Inc. | United States | Synergetics VersaVit | K121675 (2012) |
| Medical Technical Products | United States | US Handpiece, Standard Irrigation Sleeve, 20GA, Pack 5 Vinyl Cover, M3000 Aspiration Tip, .3mm, Straight Operators Manual, M3000 Operators Manual, M2000, Premium, Chinese | K940083 (1994) |
| This AG | Switzerland | SOPHI SOPHI A Phaco Set Sophi - 20G/Curved Cassette Peristaltic Sophi ECO Phaco Set Sophi - 20G/30° Phaco Set Sophi - 21G/30° | K250501 (2025) |
| MANI, INC. | – | MANI Infusion Cannula MANI Trocar MANI Trocar Kit | registered |
| Peregrine Surgical , Ltd. | United States | 20GA Soft Tip Aspirating Laser Probe - Iridex 23GA Hard Tip Aspirating Laser Probe - Alcon 20GA Hard Tip Aspirating Laser Probe - Iridex 20GA Aspirating Laser Probe, SMA905 20GA Soft Tip Aspirating Laser Probe - Alcon 20GA Aspirating Laser Probe, SMA906 | K980399 (1998) |
| AKTIVE SRL | Italy | Trocar set 20G with removable valve Trocar 23G with removable valve Trocar set 25G with removable valve Trocar set 27g with removable valve Trocar set 23G with removable valve Trocar 27G with removable valve | registered |
| MICROVISION, INC. | United States | – | registered |
| Carl Zeiss Meditec Cataract Technology, Inc. | United States | MICOR Auto I/A MICOR extractor MICOR drive | K243395 (2025) |
| FCI S A S FCI 20 22 | – | Ophthalmic trocar | registered |
| AMERICAN CONTRACT SYSTEMS, INC. | – | ACS | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Symmetry Surgical Symmetry Adson | registered |
| RUMEX INTERNATIONAL CORP. | United States | Rumex | registered |
| Lensar, Inc. Present in Europe in other categories | United States | LENSAR LLS-fs 3D | K122829 (2012) |
| Geuder Aktiengesellschaft | – | N.A. | registered |
| A.R.C Laser GmbH Present in Europe in other categories | United States | – | K170183 (2017) |
| AMC | United States | – | registered |
| ARMM INC. | United States | – | registered |
| AUROLAB | India | – | registered |
| AURORA SURGICAL, LLC | United States | – | registered |
| Abbott Medical Optics, Inc. | United States | – | K160236 (2016) |
| Alcon Research, Ltd. | United States | – | K191650 (2019) |
| Appasamy Associates Private Limited (MN Kuppam) Present in Europe in other categories | India | – | registered |
| Appasamy Associates Private Limited (Thiruvandar Koil) Present in Europe in other categories | India | – | registered |
| Autocam Medical | United States | – | registered |
| B. Ali Impex | Pakistan | – | registered |
| Belle Healthcare Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| COASTLINE INTERNATIONAL, INC. | United States | – | registered |
| Can Technomed Trading LTD. | Canada | – | registered |
| Carl Zeiss Meditec Cataract Technologies | United States | – | K262097 (2026) |
| D.O.R.C. Dutch Ophthalmic Research Center (International) B. | Netherlands | – | registered |
| Falcon Surgical Co. (Pvt.) Ltd. Present in Europe in other categories | Pakistan | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| Garish Apparels | Pakistan | – | registered |
| HARMAC MEDICAL PRODUCTS, INC. | United States | – | registered |
| ISCON SURGICALS, LTD. | India | – | registered |
| Jabil Inc. | United States | – | registered |
| Lake Region Medical | United States | – | registered |
| MANI, INC. (HEAD OFFICE) | Japan | – | registered |
| MEDONE SURGICAL, INC. | United States | – | registered |
| MEED SKILLS SURGICAL | Pakistan | – | registered |
| MOOG, INC. | United States | – | registered |
| Medicar Health Inc. | United States | – | registered |
| Modo Inc | United States | – | registered |
| PROVIDENCE ENTERPRISE LTD. | Hong Kong SAR China | – | registered |
| Psi/Eye-Ko, Inc. | United States | – | registered |
| QSA SURGICAL (PVT) LTD. | Pakistan | – | registered |
| Raico, LLC | United States | – | K192418 (2020) |
| Rg Medical USA | United States | – | registered |
| Roechling Medical Rochester, L.P. | United States | – | registered |
| SPARTECH INSTRUMENTS & CO. | Pakistan | – | registered |
| STERIMEDIX LTD. | United Kingdom | – | registered |
| STERIPAC GMBH | Germany | – | registered |
| Saint-Gobain Performance Plastics | United States | – | registered |
| Sanmina Corporation | United States | – | registered |
| Speedway Surgical Co. | India | – | registered |
| Strub Medical GmbH & Co. KG Present in Europe in other categories | Germany | – | registered |
| Technolas Perfect Vision GmbH Present in Europe in other categories | United States | – | registered |
| Univac Precision Engineering Pte Ltd | Singapore | – | registered |
| Viant Medical, LLC | United States | – | registered |
| Victor Medical Instruments Co., Ltd | China | – | registered |
| Visioncare Devices, Inc. | United States | – | K212763 (2022) |
| Vista Ophthalmics, LLC | United States | – | K220030 (2022) |
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