Instruments for functional explorations and therapeutic interventions
Ophthalmology instruments
EMDN code Z1212
Manufacturers registered in Europe (EUDAMED) 176
- 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) 542
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 |
|---|---|---|---|
| OPHTHALMED LLC | United States | – | K142830 (2015) |
| 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 | Castroviejo Speculum Mellinger Eye Speculum Jameson Caliper BARRAQUER LID SPECULUM 24B SPECULUM ADJUSTABLE 6B Bausch + Lomb | K261264 (2026) |
| Ocular Instruments, Inc. | United States | MaxLight® Triple Two Panfundus Binocular Indirect Lens (Blue) MaxField® High Mag 78 Slit Lamp Indirect Lens (Red) MaxLight® High Mag 78D Slit Lamp Indirect Lens MaxLight® 28D Binocular Indirect Lens 132D Indirect Vitrectomy Lens MaxLight® Triple Two Panfundus Binocular Indirect Lens (Red) | K935302 (1994) |
| Med Saver, Inc. | – | MSI Precision Specialty Instruments | registered |
| KATENA PRODUCTS, INC. | – | Primary Lens Set, 28D, 90D, 4 Mirror Primary Lens Set, 28D, 90D, 3 Mirror Glaukos SCHIOTZ TONOMETER KATENA Ophthalmic Speculum | registered |
| Peregrine Surgical , Ltd. | United States | 27GA Curved Laser Probe - Iridex 27GA Curved Illuminating Laser Probe - Iridex 25GA Curved Illuminating Laser Probe - Short 27GA Curved Illuminating Laser Probe - DORC 25GA Curved Illuminating Laser Probe 27GA Curved Illuminating Laser Probe - Alcon | K233653 (2024) |
| AMBLER SURGICAL CORP. | – | Ambler Surgical Ambler Value Line | registered |
| KATALYST SURGICAL LLC | United States | Titanium Closed Loop Wire Speculum Titanium Nagahara Wire Speculum, Nasal Placement, 52mm Stainless Steel Closed Loop Wire Speculum, Heavy Gauge Stainless Steel Lindstrom-Chu Aspirating Speculum, K-Wire Titanium Shapira Eye Speculum Titanium Alfonso Eye Speculum, Pediatric | K140362 (2014) |
| Bernell | – | Bernell | registered |
| SONTEC INSTRUMENTS, INC. | United States | HEINE MPACK UNPLUGGED BATTERY HEINE LI-ION BATTERY HEINE MPACK COMPLETE HEINE MPACK HEINE - MPACK PLUG-IN TRANSFORMER HEINE - LITHIUM ION BATTERY | registered |
| OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | – | Pentacam AXL Wave Park 1 GONIO ready® 200 for f=200 GONIO ready® 175 for f=175 GONIO ready® CL Corvis STL | registered |
| Synergetics, Inc. | United States | Synergetics VersaVit | K143123 (2015) |
| FCI S A S FCI 20 22 | – | PRECIVIA® Version I PRECIVIA® Version P 90° ADJUSTABLE LASER PROBE, 23G NIDEK T.CURVED ILLUM LASER PROBE,25G QUANTEL & 19G NEEDLE STRAIGHT LASER PROBE, 20G DORC STRAIGHT LASER PROBE, 20G IRIDEX/B&L | registered |
| SKLAR CORPORATION | – | Sklar Sklar® | registered |
| Amico Diagnostic Incorporated Present in Europe in other categories | United States | Amico Diagnostic Station Amico Diagnostic Wallboard Amico Diagnostic Rollstand Amico Diagnostic Ophthalmoscope Amico Diagnostic Aneroid | K131939 (2014) |
| Walcott Rx Product Inc | – | Walcott Rx Products | registered |
| AURORA SURGICAL, LLC | United States | Ophthalmic Speculum Kershner Speculum | registered |
| Avalign Technologies, Inc. | United States | Millennium Avalign | registered |
| Crestpoint Management Limited | – | MR PHACO | registered |
| SIE AG, Surgical Instrument Engineering | Switzerland | Procedure Pack FEMTO LDVᵀᴹ Intershields FEMTO LDV SIM-LASIK Pack Procedure Pack Z8 FEMTOLDV | K213559 (2022) |
| LUNEAU TECHNOLOGY OPERATIONS | France | VISIONIX Carl Zeiss Meditec ESSILOR RODENSTOCK ZEISS Visionix VX650 | K202221 (2021) |
| Optego Vision USA Inc. | United States | Optego | registered |
| KRISHNA IMPORTS INC | – | Stephens Instruments | registered |
| DAUD JEE MFG. CO Present in Europe in other categories | Pakistan | LESTER-BURCH EYE SPECULUM CLARK SPECULUM BABY COOK EYE SPECULUM, MD #2 SOLID LIEBERMAN ASPIR SPEC CHU SOLID 15MM LIEBERMAN SPECULUM SOLID LG LIEBERMAN ASPIR SPEC K-WIRE 15MM | registered |
| U.S. OPHTHALMIC, L.L.C. | United States | Gilras Eli Ezer LuxVision LuxVsion | K080776 (2008) |
| Ellex Medical Pty, Ltd. Present in Europe in other categories | Australia | Ellex UltraQ Reflex Solo 2RT Integre Pro Scan Yellow Tango Neo | K222395 (2022) |
| 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) |
| 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, schiötz B tonometer, inclined scale, silver | K964338 (1997) |
| INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories | United States | Integra® Miltex® Integra® Jarit® | registered |
| Ion Vision, Inc | United States | DirectView 4 Mirror NF w/ Handle DirectView 3 Mirror NF eZView 30D DirectView 1 Mirror eZView 124 SP OmniView 85 | registered |
| RUMEX INTERNATIONAL CORP. | United States | Rumex | registered |
| Lightmed Corp. Present in Europe in other categories | Taiwan | TruScan Pro Lightlas SeLecTor Deux SYL-9000 YAG Laser LightLas 532 LightLas 577 LightLas 810 | K190448 (2019) |
| PHARMA SEPT MEDICAL PRODUCTS (1995) LTD. | – | Microscope Cover LEICA 137/380 7.00 HLT Microscope Cover ZEISS "MD" 115/260 6.50 Microscope Cover ZEISS 137/380 6.50 HLT Microscope Cover LEICA 115/300, 7 HLT Microscope Cover LEICA 115/210 W/DRAWSTRING HLT Microscope Cover MITAKA 137/380 HLT | registered |
| MICROSPECIALITIES, INC. | – | – | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Symmetry Allen-Schiotz Symmetry Barraquer Symmetry Lieberman Symmetry Cook Symmetry Farrior Symmetry Guyton-Park | registered |
| COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL | – | S4 OPTIK LUMENIS IRIDEX ALCON | registered |
| 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) |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. Present in Europe in other categories | China | TIANNUO / TNMED | registered |
| Vortex Surgical, Inc. | United States | Vortex Surgical Inc Vortex Surgical Inc. 23ga Bending Laser Probe - Iridex Compatible 27ga Curved Laser Probe 25ga Bending Laser Probe - Alcon Compatible 23ga Straight Laser Probe | K220263 (2022) |
| WEXLER SURGICAL, INC. | United States | Wexler Surgical, Inc. | registered |
| NOVO SURGICAL, INC. | – | Novo Surgical Inc. Novo Surgical Novo Surgical Inc | registered |
| EPSILON EYE CARE PRIVATE LIMITED | – | Epsilon USA | registered |
| Fresnel Prism & Lens Company | United States | FRESNEL PRISM AND LENS | registered |
| Geuder Aktiengesellschaft | – | N.A. | registered |
| Diamatrix | – | Diamatrix Diamatrix Ltd. | registered |
| Topcon Medical Laser Systems, Inc. | United States | PASCAL Synthesis PASCAL Laser Indirect Ophthalmoscope PACSAL Synthesis PASCAL Synthesis TwinStar | K180402 (2018) |
| Alma Lasers, Inc. Present in Europe in other categories | United States | FemiLift Sleeve FemiLift Slim Sleeve 24 iPixel Module - Line Scan With Wheel and Support FemiLift Handpiece Femilift HP & Camera Handpiece Focus 50mm for CO2 Alma | registered |
| INAMI & CO., LTD. | Japan | INAMI Inami Ophthalmic Instruments | registered |
| Jedmed Instrument Co. | United States | JEDMED | registered |
| BOSS INSTRUMENTS, LTD., INC. | – | BOSS Instruments | registered |
| FUSION ORTHOPEDICS, LLC | United States | PolyLock Small Bone Hammer Tech PolyLock Ankle DynaBridge IntraLock LapiLock | registered |
| Psi/Eye-Ko, Inc. | United States | Anodyne Surgical Walcott Rx Products | registered |
| FORUS HEALTH PRIVATE LIMITED | – | 3nethra Ovitz Aberrometer | registered |
| STERIS Corporation Present in Europe in other categories | United States | V. Mueller | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | PILLING | registered |
| Hayden Medical, Inc. | – | Hayden Medical | registered |
| MDT SP Z O O | Poland | Ophthalmic Electric Table | registered |
| HNM STAINLESS, LLC. | – | HNM MEDICAL | registered |
| Medicon eG. Chirurgiemechaniker-Genossenschaft | – | Medicon | registered |
| RIGHT MFG. CO., LTD. | Japan | Visionix | registered |
| INNOVA Medical Ophthalmics Inc | Canada | S4Optik Lombart S4 OPTIK | registered |
| Interacoustics A/S Present in Europe in other categories | Denmark | Interacoustics | K200534 (2020) |
| MEDTRONIC PS MEDICAL, INC. | United States | EXTERNAL DRAINAGE MONITORING Becker | registered |
| 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) |
| ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION | United States | ASSI | registered |
| Chongqing Kanghuaruiming S&T Co., Ltd.. | China | – | K171877 (2017) |
| Phoenix Clinical | – | Phoenix ICON & FA Module with Training Kit Phoenix ICON Cart System Diffuser Phoenix ICON with Training Kit Phoenix ICON GO with Training Kit Phoenix ICON GO Control Box | registered |
| AMA Optics, Inc. | United States | AMA Optics Eye Chart AMA Optics Retinometer AMA Optics ETDRS AMA Optics Brightness Acuity Meter AMA Optics Occluder AMA Optics Lens Holder | registered |
| Beaver-Visitec International, Inc. | United States | Malosa Medical Visitec® | K240615 (2025) |
| MANI, INC. | – | MANI Infusion Cannula MANI Trocar MANI Trocar Kit | registered |
| OPTOS PUBLIC LIMITED COMPANY | – | Panoramic Ophthalmoscope OPTOS ADVANCE IMAGE SERVER OCT Ophthalmoscope Panoramic Opthalmoscope Optos OCT/SLO | registered |
| CHARMANT INC. | Japan | Aspirating Speculum(S) Wire Speculum Double Loop Open Blade Speculum with Locking Screw Speculum Parallel OKA Speculum Wire Speculum with Blade | registered |
| INVENTIS SRL Present in Europe in other categories | Italy | VNG Synapsys VHIT | K242726 (2025) |
| NEOLIGHT LLC | United States | Neolight | K223575 (2023) |
| Ningbo Ming Sing Optical R & D Co., Ltd. | China | AUTO REF/KERATOMETER LCD Chart monitor Ophthalmic unit | registered |
| R & D Batteries, Inc. | United States | R&D Batteries, Inc. | K942034 (1994) |
| 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 |
| Lensar, Inc. Present in Europe in other categories | United States | LENSAR LLS-fs 3D LLS/ALLY ALLY | K220259 (2022) |
| Medetz Surgical Instruments LLC | – | Medetz Surgical Instruments Lid Speculum | registered |
| Virtual Field, Inc. | United States | Virtual Field Carrot | registered |
| ADVANCE MEDICAL DESIGNS, INC. Present in Europe in other categories | United States | UNBRANDED | registered |
| BR Surgical, LLC | – | BR Surgical, LLC | registered |
| Ecleris | United States | VNG 3D PROCAM HD 2D BEAM SPLITTER | registered |
| Lkc Technologies, Inc. | United States | RETeval™ | registered |
| MICROVISION, INC. | United States | – | registered |
| Hasa Optix | Belgium | Sterile, Single Use, Lieberman Adjustable Speculum, V-Shaped Wire, L 65mm Sterile,Single Use,Adjustable Speculum,Speculum,14mm Round Solid Blades,L 65mm Sterile, Single Use, Kratz Barraquer Wire Speculum, 13.5mm Open Blades Sterile, Single Use, Speculum Adjustable Full Rounded Blades Sterile, Single Use, Lindstrom-Chu Aspirating Speculum, L 65mm Sterile, Single Use, Wire Speculum, 14mm Open Blades, L 45mm | registered |
| Leica Microsystems (Schweiz) AG Present in Europe in other categories | United States | M822 Optics Carrier RUV800 WD175 PROVEO 8 Optics Carrier PROVEO 8 F42 Leica RUV800 WD200 PROVEO 8 CT42 | registered |
| Nova Eye, Inc. | United States | iLumin iTrack 250A iTrack Advance iTrack 250E | K253468 (2026) |
| Surgical Design, Inc. | United States | ROYAL TEK Surgical Design | registered |
| Virtual Vision Health | – | Virtual Eye Software Virtual Eye ELITE S Virtual Eye PRO | registered |
| Gobiquity, Inc. | United States | GoCheck MultiScreener GoCheck Kids | registered |
| Illuminix Industries LLC | – | ILLUMINIX | registered |
| MEDTRAK VNG, INC. | United States | MedTrakVNG MobiTrak System MobiTrakVNG Receiver MedTrakVNG Footswitch MedTrakVNG Interface Controller MedTrakVNG Goggle MobiTrak Software v3.00 | registered |
| Norlase ApS | Denmark | Norlase ECHO photocoagulator Norlase LION photocoagulator Norlase Leaf photocoagulator Norlase LYNX photocoagulator | K242397 (2024) |
| Optimedica Corporation | United States | LIQUID OPTICS INTERFACE CATALYS SYSTEM | K161455 (2016) |
| Plusoptix GmbH | Germany | plusoptiX 12 plusoptiX 16 | registered |
| REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED | India | Remidio | K252120 (2025) |
| Trevi Technology, Inc. | – | IBEX 2-step LED slit lamp IBEX 5-step LED slit lamp IBEX Manual Refractor Applanation Tonometer IBEX Wireless LED Binocular Indirect Ophthalmoscope IBEX LCD digital acuity chart | registered |
The 100 most active manufacturers are shown, out of 542.
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