Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsVarious ophtalmology instruments
Various ophtalmology instruments - other
EMDN code Z12129099
Manufacturers registered in Europe (EUDAMED) 14
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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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) 208
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 |
|---|---|---|---|
| KATENA PRODUCTS, INC. | – | Ophthalmic Speculum Oph. Spec. OPH. SPECULUM Ophthlamic Speculum MIYAJIMA ADJUSTABLE SPECULUM YU-MORGAN XEN SPECULUM RIGHT | registered |
| Med Saver, Inc. | – | MSI Precision Specialty Instruments | registered |
| AMBLER SURGICAL CORP. | – | Ambler Surgical Ambler Value Line | registered |
| SONTEC INSTRUMENTS, INC. | United States | BARRAQUER WIRE SPECULUM BLACK FARRIOR EAR SPECULA FARRIOR EAR SPECULA Wire Speculum GRUBER EAR SPECULA LIEBERMAN SPECULUM | registered |
| SKLAR CORPORATION | – | Sklar Sklar® | registered |
| 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 |
| 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 | 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 |
| OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | – | Dovetail for BIOM SDI 4e electrically SDI 4c for motorized focus of BIOM 4c(l) SDI 4m mechanically Distancing plate for Möller-Wedel adapter for BIOM Reduction lens for f = 175 mm for BIOM 5m/c | registered |
| SURTEX INSTRUMENTS LTD. Present in Europe in other categories | United Kingdom | Surtex | registered |
| INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories | United States | Integra® Jarit® Integra® Miltex® | registered |
| 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 |
| RUMEX INTERNATIONAL CORP. | United States | Rumex | registered |
| WEXLER SURGICAL, INC. | United States | Wexler Surgical, Inc. | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Symmetry Barraquer Symmetry Lieberman Symmetry Cook Symmetry Farrior Symmetry Guyton-Park Symmetry Kratz-Barraquer | registered |
| NOVO SURGICAL, INC. | – | Novo Surgical Inc. Novo Surgical Novo Surgical Inc | registered |
| EPSILON EYE CARE PRIVATE LIMITED | – | Epsilon USA | 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 | registered |
| Diamatrix | – | Diamatrix Diamatrix Ltd. | registered |
| Geuder Aktiengesellschaft | – | N.A. | registered |
| MORIA SA Present in Europe in other categories | France | MORIA ONE | registered |
| BOSS INSTRUMENTS, LTD., INC. | – | BOSS Instruments | registered |
| Psi/Eye-Ko, Inc. | United States | Anodyne Surgical Walcott Rx Products | 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 |
| HNM STAINLESS, LLC. | – | HNM MEDICAL | registered |
| Medicon eG. Chirurgiemechaniker-Genossenschaft | – | Medicon | registered |
| ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION | United States | ASSI | registered |
| Ocular Instruments, Inc. | United States | Inverter Vitrectomy System Set For Leica Type Microscopes Inverter Vitrectomy System Set For Zeiss Type Microscopes Inverter Vitrectomy System For Zeiss Type Microscopes Inverter Vitrectomy System For Leica Type Microscopes Peyman-Wessels-Landers 132D Upright Vitrectomy Lens Holder Landers Lens Forceps | registered |
| Alcon Laboratories, Inc. Present in Europe in other categories | United States | LuxOR UNITY LuxOR Revalia | K920641 (1992) |
| Beaver-Visitec International, Inc. | United States | Malosa Medical Visitec® | 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 |
| Topcon Corporation Present in Europe in other categories | Japan | COMPUTERIZED LENSMETER CL-300 PRISM COMPENSATOR for LENSMETER LM-8 TV RELAY LENS TL-6A TV RELAY LENS TL-7A BEAM SPLITTER MS-BS03-50/50 TL-5A | registered |
| INAMI & CO., LTD. | Japan | INAMI | registered |
| Medetz Surgical Instruments LLC | – | Medetz Surgical Instruments Lid Speculum | registered |
| ADVANCE MEDICAL DESIGNS, INC. Present in Europe in other categories | United States | UNBRANDED | registered |
| BR Surgical, LLC | – | BR Surgical, LLC | registered |
| Munich Surgical Imaging GmbH Present in Europe in other categories | Germany | SeeLuma Digital Binoculars Module SeeLuma SeeLuma Binoculars Heidelberg OPERA SeeLuma Digital Binoculars Upgrade Kit SeeLuma Re-Sterilizable Caps | 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 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. Present in Europe in other categories | China | TIANNUO / TNMED | registered |
| Nidek, Inc. Present in Europe in other categories | United States | AUTO LENSMETER | K884188 (1988) |
| Ecleris | United States | PROCAM HD 2D BEAM SPLITTER | registered |
| A1 Medical GmbH | Germany | Lieberman Eye Speculum Kratz-Barraquer Wire Speculum Mod. Krumeich Eye Speculum | registered |
| ELMED INCORPORATED | United States | ELMED INCORPORATED ELMED | registered |
| Gimmi GmbH Present in Europe in other categories | Netherlands | Gimmi | registered |
| KLS-Martin L.P. Present in Europe in other categories | Germany | SPECULUM | registered |
| Tomey Corporation USA Present in Europe in other categories | United States | AUTO LENSMETER | registered |
| Aesculap, Inc. Present in Europe in other categories | United States | AESCULAP | registered |
| Haag-Streit AG Present in Europe in other categories | Switzerland | HS Hi-R NEO 900 Microscope HS NEO 900 Carrier Metis 900 | registered |
| Surgical Design, Inc. | United States | Surgical Design ROYAL TEK | registered |
| Surgistar, Inc. | United States | SURGISTAR | registered |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | DeRoyal | registered |
| ESSILOR INTERNATIONAL Present in Europe in other categories | United States | ALM700 ALM500 ALM800 | registered |
| LUNEAU TECHNOLOGY OPERATIONS | France | Visionix | registered |
| OPTOMIC ESPAÑA SA Present in Europe in other categories | Spain | Optomic | registered |
| REXXAM CO., LTD. Present in Europe in other categories | Japan | Rexxam | registered |
| RZ-Medizintechnik GmbH Present in Europe in other categories | Germany | RZ Medizintechnik GmbH | registered |
| Shenzhen CERTAINN Technology Co., Ltd. Present in Europe in other categories | China | MOPTIM | registered |
| TAKAGI SEIKO CO.,LTD. Present in Europe in other categories | Japan | TAKAGI MARCO | registered |
| CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD Present in Europe in other categories | China | Lensmeter | registered |
| DR.FRIGZ INTERNATIONAL(PVT)LTD, Present in Europe in other categories | Pakistan | EYE SPECULA EYES SPECULUM | registered |
| Eyoto, Inc. Present in Europe in other categories | United Kingdom | Atlas | registered |
| FCI S A S FCI 20 22 | – | PRECIVIA® Version I PRECIVIA® Version P | registered |
| LABOTECH MICROSCOPES INDIA PRIVATE LIMITED | India | Labomed Stella OPH microscope with wall mount Labomed Stella OPH microscope | registered |
| REICHERT, INC. Present in Europe in other categories | United States | LensChekPro LensChekPlus | registered |
| VIEW-M TECHNOLOGY CO., LTD. Present in Europe in other categories | South Korea | Auto Lensmeter | registered |
| 6 OVER 6 VISION LTD | Israel | MyRx LensScaner | registered |
| Adler, Inc. | – | Adler Instrument Company | registered |
| Lombart Brothers, Inc. | – | S4Optik AL 2000 Digital Lensmeter | registered |
| U.S. OPHTHALMIC, L.L.C. | United States | Eli Ezer | registered |
| Visionsense, Ltd. | United States | VS3 Pneumatic Arm Tubing Set | registered |
| 123 SEE | United States | – | registered |
| APRAMED INDUSTRIA E COMERCIO DE APARELHOS MEDICOS LTDA | Brazil | – | registered |
| ARI Medical Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| ASANUS MEDIZINTECHNIK GMBH | Germany | – | registered |
| ASOL Co.,LTD | China | – | registered |
| Acheron Instruments (Pvt.) Ltd. Present in Europe in other categories | Pakistan | – | registered |
| Akriti Ophthalmic Private Limited | India | – | registered |
| Alltion (Wuzhou) Co., Ltd. Present in Europe in other categories | China | – | registered |
| Amann Medical GmbH & Co. KG | Germany | – | registered |
| Apothecaries Sundries Mfg Pvt Ltd | India | – | registered |
| Appasamy Associates Private Limited (MN Kuppam) Present in Europe in other categories | India | – | registered |
| Appasamy Associates Private Limited Present in Europe in other categories | India | – | registered |
| Appasamy Associates Private Limited (Thiruvandar Koil) Present in Europe in other categories | India | – | registered |
| Armatech International | Pakistan | – | registered |
| Asuzna | United States | – | registered |
| B&H Surgical Instrument | Pakistan | – | registered |
| BIS MASTERMED s.r.o. | Slovakia | – | registered |
| Belle Healthcare Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| C.S.O. S.R.L. | Italy | – | registered |
| CJ-Optik GmbH & Co. KG Present in Europe in other categories | Germany | – | registered |
| Choose Surgical Instruments | Pakistan | – | registered |
| Coba Biomedical PTY (Ltd) | South Africa | – | registered |
| Corza Medical, Inc. | United States | – | registered |
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