Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instrumentsENT endoscopy instruments
Rhinoscopes
EMDN code Z12021008
Manufacturers registered in Europe (EUDAMED) 16
- 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) 87
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 |
|---|---|---|---|
| MEDTRONIC XOMED, INC. Present in Europe in other categories | United States | ENDO-SCRUB® SLIDE-ON® ENDOSHEATH® Sharpsite® SLIDE-ON® ENDO-SCRUB™ 2 | K173855 (2018) |
| Jedmed Instrument Co. | United States | JEDMED | K944671 (1995) |
| Olympus Medical Systems Corp. Present in Europe in other categories | Japan | RHINO-LARYNGO VIDEOSCOPE RHINO-LARYNGOFIBERSCOPE DISPOSABLE BIOPSY FORCEPS Single Use Grasping Forceps MINIATURE LIGHT SOURCE VISERA 4K UHD XENON LIGHT SOURCE | K252050 (2026) |
| SOPRO-COMEG GmbH | Germany | Sinuscope Suction-irrigation-tube Handle for sinuscopy Suction-irrigation-handle Handle for sinuscope Suction irrigation sheath | K153701 (2016) |
| Pentax of America, Inc. Present in Europe in other categories | United States | SINUSCOPE VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE FIBER LARYNGOSCOPE FIBER NASO PHARYNGO LARYNGOSTROBOSCOPE SINUSCOPES | K220465 (2022) |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | InstaClear Gyrus ACMI GYRUS ACMI, INC Olympus EVONOS | K152531 (2016) |
| NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | United States | AED | K170285 (2017) |
| Medos International Sàrl Present in Europe in other categories | Switzerland | MITEK | registered |
| Ecleris | United States | Sinuscope Nasopharyngoscope, Flexible | K131323 (2014) |
| HOYA CORPORATION | United States | PENTAX Medical PENTAX VIVIDEO | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | Precision S 4K FocESS | K191102 (2019) |
| Medrobotics Corporation | United States | FLEX | K170453 (2017) |
| Prosidio LLC | United States | Prosidio | registered |
| BR Surgical, LLC | – | BR Surgical, LLC | registered |
| Shenzhen HugeMed Medical Technical Development Co., Ltd. Present in Europe in other categories | China | Single-Use Rhinolaryngoscope Image Processor | K232435 (2024) |
| Smith & Nephew, Inc. Present in Europe in other categories | United States | – | K970247 (1997) |
| INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories | United States | Integra® Jarit® | registered |
| MEDIVISION, INC. | United States | MEDIVISION MEDIVISIION | registered |
| Optim, LLC | United States | ENT 3.6FP30 Nasopharyngoscope Entity XL Plus Nasopharyngoscope ENTity Nasopharyngoscope ENTity XL Nasopharyngoscope ENTity SD 45X Nasopharyngoscope ENTity XL (PA Compatible) Nasopharyngoscope | K254133 (2026) |
| Hunan Vathin Medical Instrument Co., Ltd. Present in Europe in other categories | China | Single-Use Flexible Rhinolaryngoscope | K230536 (2023) |
| Avalign Technologies, Inc. | United States | Millennium Avalign | registered |
| Clarus Medical, LLC | United States | Clarus Video Airway System PocketScope, pocket endoscope SOS Malleable Stylet, Adult, Green Line with Stop SOS Shikani Optical Stylet, Adult SOS Shikani Optical Stylet, Pediatric SOS Malleable Stylet, Green Line (Adult) | registered |
| FENTEX medical GmbH Present in Europe in other categories | Germany | FENTEX | registered |
| Ambu A/S Present in Europe in other categories | Denmark | aScope™ 4 RhinoLaryngo Slim aScope™ 4 RhinoLaryngo Intervention | K190972 (2019) |
| AMERICAN MEDICAL ENDOSCOPY, INC. | United States | Strauss Surgical | registered |
| Grace Medical, Inc. | United States | EndoEar™ ENDOSCOPE, 3MM X 150MM, 30 DEG. EndoEar™ ENDOSCOPE, 3MM X 150MM, 70 DEG. EndoEar™ ENDOSCOPE, 3MM X 150MM, 45 DEG. EndoEar™ ENDOSCOPE, 3MM X 150MM, 0 DEG. | registered |
| ATMOS MedizinTechnik GmbH & Co. KG Present in Europe in other categories | Germany | ATMOS | K232015 (2023) |
| COGENTIX MEDICAL, INC. Present in Europe in other categories | United States | Portable LED Light Source UNITY 9000 UNITY 9100 | registered |
| H & A Mui Enterprises Inc | Canada | Mui Scientific Henke-Sass Wolf | K222587 (2023) |
| Smartsurgn Inc. | United States | Non-ICG 4mm Sinuscope (0 Deg) Non-ICG 4mm Sinuscope (30 Deg) Non-ICG 4mm Sinuscope (70 Deg) | registered |
| Zhuhai Wesee Meditech Co., Ltd. Present in Europe in other categories | China | Wesee | K253184 (2026) |
| Acclarent, Inc. | United States | ACCLARENT CYCLOPS | K132433 (2014) |
| MEDIMAGING INTEGRATED SOLUTION INC. Present in Europe in other categories | China | MiiS Horus scope MiiS Horus Video Box | registered |
| Scivita Medical Technology Co., Ltd. Present in Europe in other categories | China | 4K UHD Camera System | registered |
| ZSQUARE LTD | Israel | Zsquare ENT-Flex Console Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE | K220004 (2022) |
| Bosma Enterprises | – | Ambu | registered |
| Hayden Medical, Inc. | – | Hayden Medical | registered |
| INVOTEC INTERNATIONAL, INC. | United States | Clearview Scope Cover | K080740 (2008) |
| PACIFICMD BIOTECH, LLC | – | VISIONAIR | registered |
| 3nt Medical , Ltd. | Israel | – | K202727 (2021) |
| Almikro GmbH & Co. KG | Germany | – | registered |
| BOWA-ELECTRONIC GMBH & CO. KG Present in Europe in other categories | Germany | – | registered |
| Bruetsch Technology AG | Switzerland | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CHG-MERIDIAN CANADA LTD | Canada | – | registered |
| COMMAND MEDICAL PRODUCTS, LLC | United States | – | registered |
| Covidien, LLC Present in Europe in other categories | United States | – | registered |
| Depuy Mitek, A Johnson & Johnson Company | United States | – | registered |
| Diversified Plastics, Inc | United States | – | registered |
| EUSA GLOBAL LLC Present in Europe in other categories | United States | – | registered |
| Faulhaber Pinzetten Ohg | Germany | – | registered |
| Grumpy Innovation, Inc. | United States | – | K243639 (2025) |
| HGR INSTRUMENTE GMBH | Germany | – | registered |
| HOYA Corporation PENTAX Division | United States | – | registered |
| Ian Jamieson Pty Ltd | Australia | – | registered |
| Integra LifeSciences Corporation Present in Europe in other categories | United States | – | registered |
| JR MONTAGEARBEITEN | Germany | – | registered |
| KARL STORZ Endoscopy-America, Inc. | United States | – | K200740 (2020) |
| KIMBALL SOLUTIONS GROUP, LLC | United States | – | registered |
| Kunststoff Helmbrechts AG | Germany | – | registered |
| Linemaster Switch Corp. | United States | – | registered |
| MDTGlobal, a.s. | Slovakia | – | registered |
| MIC International | United States | – | registered |
| Medical Resale PTY Limited | Australia | – | registered |
| Medical Wholsale Suplies, Inc, | Canada | – | registered |
| Medicaltek Co., Ltd. Present in Europe in other categories | Taiwan | – | K234096 (2024) |
| Medicon EG | Germany | – | registered |
| Medimaging Integrated Solution, Inc (Miis) Present in Europe in other categories | Taiwan | – | K214050 (2022) |
| Medtronic, Inc. Present in Europe in other categories | United States | – | registered |
| Mi3 Limited | United Kingdom | – | registered |
| NZ Biomed Limited | New Zealand | – | registered |
| Nissha Medical Technologies Present in Europe in other categories | United States | – | registered |
| Olympus America, Inc. Present in Europe in other categories | United States | – | K021073 (2002) |
| PLEXUS CORP. | United States | – | registered |
| Pentax Medical Company Present in Europe in other categories | United States | – | K171011 (2018) |
| Primo Medical Group, Inc | United States | – | registered |
| Resnent, LLC | United States | – | K241731 (2025) |
| Rg Medical USA | United States | – | registered |
| Richard Wolf GmbH Present in Europe in other categories | Germany | – | registered |
| Schoelly Fiberoptic GmbH | Germany | – | K143673 (2015) |
| Straits Orthopaedics (Mfg) Sdn Bhd | Malaysia | – | registered |
| Stryker Instruments Present in Europe in other categories | United States | – | K261544 (2026) |
| Sutter Medizintechnik GmbH Present in Europe in other categories | Germany | – | registered |
| VEENAK INTERNATIONAL LIMITED | United Kingdom | – | registered |
| asap GmbH | Germany | – | registered |
| jr-medizintechnik GmbH & Co KG | Germany | – | registered |
| medi-G GmbH | Germany | – | registered |
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