Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsOphtalmology assessments and diagnosis instruments
Tonometers
EMDN code Z12120122
Manufacturers registered in Europe (EUDAMED) 25
- 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) 48
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 |
|---|---|---|---|
| LUNEAU TECHNOLOGY OPERATIONS | France | VISIONIX RODENSTOCK ESSILOR ZEISS Visionix VX650 Luneau | registered |
| Ocular Instruments, Inc. | United States | Varley Barrquer 90mm Hg Tonometer Terry Scale Barraquer 15-21mm Hg Tonometer Griffin Barraquer 30-50mm Hg Tonometer Terry Scale Barraquer 10-15mm Hg Tonometer Barraquer 65-90mm Hg Tonometer Barraquer O-Ring Tonometer | registered |
| AMBLER SURGICAL CORP. | – | Ambler Surgical | registered |
| Accutome, Inc. | United States | AccuTip Cover Accupen | K132549 (2014) |
| Bausch & Lomb, Inc. Present in Europe in other categories | United States | Bausch + Lomb | K011199 (2001) |
| Rudolf Riester GmbH & Co. KG | Germany | schiötz B tonometer, inclined scale, silver schiötz C tonometer, inclined scale, silver schiötz A tonometer, straight scale, silver schiötz C tonometer, inclined scale, gold schiötz C tonometer, inclined scale, silver, with 4 weights | K945541 (1995) |
| Tomey Corporation USA Present in Europe in other categories | United States | NON-CONTACT TONOMETER | K073087 (2008) |
| U.S. OPHTHALMIC, L.L.C. | United States | Eli Ezer LuxVision | registered |
| COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL | – | S4 OPTIK | registered |
| Falck Medical, Inc. | United States | FMAT1 Prism B Falck Medical Multi-Function Applanation Tonometer | K151491 (2016) |
| INAMI & CO., LTD. | Japan | INAMI | registered |
| KATENA PRODUCTS, INC. | – | SCHIOTZ TONOMETER KATENA | registered |
| OPTILASA S.L. | Spain | OPTILASA | K023676 (2003) |
| SIGNUS Medizintechnik GmbH | Germany | DIPLOMAT Def. | registered |
| ZIEN MEDICAL TECHNOLOGIES, INC. | United States | CATS Tonometer CATS | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Symmetry Allen-Schiotz | registered |
| AUTOMATED OPHTHALMICS, INC. | United States | Automated Ophthalmics Softips | K992998 (2000) |
| Biomet Biologics, LLC | – | Calcibon | registered |
| INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories | United States | Integra® Miltex® | registered |
| Jedmed Instrument Co. | United States | JEDMED | registered |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. Present in Europe in other categories | China | TIANNUO / TNMED | registered |
| MEDIMAGING INTEGRATED SOLUTION INC. Present in Europe in other categories | China | MiiS | K223739 (2023) |
| OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | – | Corvis STL | registered |
| SMT Swiss Microtechnology AG Present in Europe in other categories | United States | PASCAL | K032967 (2003) |
| Trevi Technology, Inc. | – | Applanation Tonometer | registered |
| ATC Technologiess Inc. | United States | – | registered |
| C.S.O. S.R.L. | Italy | – | K022054 (2002) |
| Cats Tonometer, LLC | United States | – | K234037 (2024) |
| Company Elamed | Russia | – | K190382 (2019) |
| Corza Medical, Inc. | United States | – | registered |
| FREY SPOLKA JAWNA | Poland | – | registered |
| Friendship Industries | United States | – | registered |
| HEBUMEDICAL GMBH | Germany | – | registered |
| INFIPLAST | France | – | registered |
| INNOVA Medical Ophthalmics Inc | Canada | – | registered |
| Innokas Yhtyma Oy Present in Europe in other categories | Finland | – | registered |
| Keeler Instruments, Inc. | United States | – | K181143 (2019) |
| Kiltex Corporation | United States | – | registered |
| Luneau Sas | France | – | K162067 (2017) |
| Mariachi Oy | Finland | – | registered |
| Medimaging Integrated Solution, Inc (Miis) Present in Europe in other categories | Taiwan | – | K181260 (2019) |
| Profound Rubber Ind Sdn Bhd | Malaysia | – | registered |
| Rodenstock GmbH | Germany | – | registered |
| Rodenstock GmbHElsenheimer | Germany | – | registered |
| Shern Yeong Precise Optical Co., Ltd. | Taiwan | – | registered |
| TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD. | China | – | registered |
| Valukumpu Oy | Finland | – | registered |
| YELATMA INSTRUMENT-MAKING ENTERPRISE | Russia | – | registered |
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