Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instrumentsVarious instruments for endoscopy and mini-invasive surgery
Various instruments for endoscopy and mini-invasive surgery - hardware accessories
EMDN code Z12029080
Manufacturers registered in Europe (EUDAMED) 19
- 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) 180
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 |
|---|---|---|---|
| Surgical Direct, Inc. | United States | Surgical Direct | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | PILLING | registered |
| Fujifilm Corporation Present in Europe in other categories | Japan | FUJIFILM | K250550 (2026) |
| Hangzhou AGS MedTech Co., Ltd. Present in Europe in other categories | China | – | K213578 (2022) |
| HOYA CORPORATION | United States | PENTAX Medical PENTAX INSPIRA | registered |
| Jedmed Instrument Co. | United States | JEDMED | K954184 (1995) |
| Avalign Technologies, Inc. | United States | Millennium | registered |
| ELMED INCORPORATED | United States | ELMED INCORPORATED ELMED ELMED INCORPORTED | registered |
| Medisono, LLC Present in Europe in other categories | United States | MEDISONO | registered |
| Pentax of America, Inc. Present in Europe in other categories | United States | VIDEO COLONOSCOPE VIDEO GASTROSCOPE ENTEROSCOPE VIDEO ESOPHAGOSCOPE | K251256 (2025) |
| AMBLER SURGICAL CORP. | – | Ambler Surgical | registered |
| FENTEX medical GmbH Present in Europe in other categories | Germany | FENTEX | registered |
| Endoch Inc | – | Endoch | registered |
| Micro-Tech (Nanjing) Co., Ltd. | China | Disposable Distal Cap | K243388 (2025) |
| Smart Medical Systems , Ltd. | Israel | G-EYE Colonoscope NaviAid™ SPARKC | K220158 (2022) |
| INTEGRA MICROFRANCE Present in Europe in other categories | France | MicroFrance® | registered |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | Gyrus ACMI PlasmaKinetic GYRUS AMCI GYRUS ACMI, INC | registered |
| AMERICAN MEDICAL ENDOSCOPY, INC. | United States | Strauss Surgical | registered |
| Motus GI Medical Technologies , Ltd. Present in Europe in other categories | Israel | Pure-Vu Pure-Vu EVS System Disposable Pure-Vu EVS COLON KIT, 5 Pack MOTUS GI Endoscopy Cart (Accessory) Pure-Vu EVS Waste Bag (Accessory) Pure-Vu EVS Colon Kit, Single Pack | K232922 (2023) |
| MEDIVATORS INC. Present in Europe in other categories | United States | DEFENDO Defendo Single Use Valve Kit DEFENDO Air/Water/Suction and Biopsy Valve DEFENDO Valve and Connector Kit DEFENDO Air/Water and Suction Valves | registered |
| SCHÖLLY FIBEROPTIC GmbH Present in Europe in other categories | Germany | – | registered |
| BR Surgical, LLC | – | BR Surgical, LLC | registered |
| Guangzhou Red Pine Medical Instrument Co., Ltd. Present in Europe in other categories | China | REDPINE | K232043 (2024) |
| Sonoscape Medical Corp. Present in Europe in other categories | China | SonoScape | K222020 (2022) |
| Boston Scientific Corp Present in Europe in other categories | United States | CRE Wireguided | registered |
| Lumendi, LLC | United States | DiLumen C2 DiLumen Endolumenal Interventional Platform, 130 cm DiLumen Endolumenal Interventional Platform DiLumen Endolumenal Interventional Platform, 103 cm DiLumen EZ1, 130 cm DiLumen C1, 130 cm | K221452 (2023) |
| MICROVISION, INC. | United States | – | K982462 (1998) |
| Ecleris | United States | EVERLUX PRO EVERLUX EVERLUX MINI | registered |
| SONTEC INSTRUMENTS, INC. | United States | LIGHT GUIDE CARRIER MICROLIGHT LED MICROLIGHT ML4 LED HEADLIGHT Sontec Operating Laryngoscope Light Guide SONTEC OPERATING LARYNGOSCOPE LIGHT GUIDE CARRIER | registered |
| Spiggle & Theis Medizintechnik GmbH Present in Europe in other categories | – | Fiberglass light carrier XHL xenon spare bulb, 2.5 V Mini otoscope 3000 Fibre light carrier Light cable with iris, for head-light XHL xenon spare bulb, 3.5 V | registered |
| W.O.M. World of Medicine GmbH | United States | PNEUMOCLEAR Insufflator 50L Heating tube set for insufflation, single use HEATED HIGH-FLOW TUBE SET SMOKE EVACUATION HIGH-FLOW TUBE SET HIGH-FLOW TUBE SET | registered |
| Medrobotics Corporation | United States | FLEX | K172036 (2017) |
| KATALYST SURGICAL LLC | United States | Spetzler Lighted Suction Tube, 5 French, 140mm, Storz Conenctor Spetzler Lighted Suction Tube, 7 French 160mm, Storz Connector Spetzler Lighted Suction Tube, 5 French, 120mm, Storz Connector Spetzler Lighted Suction Tube, 5 French, 160mm, Storz Connector Spetzler Lighted Suction Tube, 7 French, 140mm, Storz Connector Spetzler Lighted Suction Tube, 3 French, 160mm, Storz Connector | K141781 (2015) |
| Lexion Medical, LLC Present in Europe in other categories | United States | Insuflow Port AP50/30 | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | SPY 1788 | registered |
| Hayden Medical, Inc. | – | Hayden Medical | registered |
| Bear-Ent, LLC | United States | BEAR | registered |
| Covidien, LLC Present in Europe in other categories | United States | Vital Vue | registered |
| SB-KAWASUMI LABORATORIES, INC. Present in Europe in other categories | Japan | SB Soft Hood /Undercut type SB Soft Hood /Straight type | registered |
| Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory) Present in Europe in other categories | – | Disposable Distal End Tape Hood | registered |
| Smith & Nephew, Inc. Present in Europe in other categories | United States | 500XL | K994084 (2000) |
| Acclarent, Inc. | United States | RELIEVA LUMA | registered |
| Actuated Medical, Inc. | United States | GripTract-GI Endoscopic Tissue Manipulator | K251041 (2025) |
| EvoEndo, Inc. | United States | EvoEndo Model LE Single-Use Gastroscope Single-Use Gastroscope 3.5/2.0 85cm DEMO Single-Use Gastroscope 3.5/2.0 85cm Single-Use Gastroscope 3.5/2.0 85cm 5-pack | K260573 (2026) |
| MARINA MEDICAL INSTRUMENTS, INC. | United States | Marina Medical | registered |
| BIOMET MICROFIXATION, INC Present in Europe in other categories | United States | – | registered |
| Medical Illumination International Inc. | United States | OptiLux LED Illuminator | registered |
| OPTOMIC ESPAÑA SA Present in Europe in other categories | Spain | Optomic | registered |
| Saneso Inc. | United States | Saneso | K210052 (2022) |
| ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION | United States | ASSI | registered |
| Ambu A/S Present in Europe in other categories | Denmark | aScope™ Colon Ambu® aScope™ Gastro Large aScope™ Gastro | K261400 (2026) |
| FIBEROPTICS TECHNOLOGY, INC. | United States | Fiberoptics Technology INC | K904378 (1991) |
| KOROS U.S.A., INC. | United States | Fiberoptic Light Port Fiberoptic Dual End Cable | registered |
| Med Saver, Inc. | – | MSI Precision Specialty Instruments | registered |
| NEPTUNE MEDICAL INC. | United States | Pathfinder® Endoscope Cap Pathfinder® CR System | K260503 (2026) |
| SUNOPTIC TECHNOLOGIES LLC Present in Europe in other categories | United States | Sunoptic Technologies | registered |
| US Endoscopy | United States | Oracle DEFENDO | registered |
| BLACK & BLACK SURGICAL, INC. Present in Europe in other categories | United States | – | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Conmed Corporation Present in Europe in other categories | United States | CONMED | registered |
| FUJIFILM medwork GmbH | Germany | FUJIFILM medwork | registered |
| Gimmi GmbH Present in Europe in other categories | Netherlands | Gimmi | registered |
| NICO CORPORATION Present in Europe in other categories | United States | NICO Myriad NOVUS NICO Myriad SPECTRA | registered |
| NOVO SURGICAL, INC. | – | Novo Surgical Inc. Novo Surgical | registered |
| Q UROLOGICAL CORPORATION | – | Q UROLOGICAL PERSISTENT AGUAMEDICINA | registered |
| Scivita Medical Technology Co., Ltd. Present in Europe in other categories | China | 4K UHD Camera System | registered |
| VISURA TECHNOLOGIES, INC. | United States | Visura TEECAD Carrier Visura TEECAD Carrier Control Unit | K180911 (2018) |
| Aspero Medical, Inc. | United States | Ancora | K260314 (2026) |
| BIOCARE MEDICAL LLC Present in Europe in other categories | – | CD138 + Cyclin D1 | registered |
| Bausch & Lomb, Inc. Present in Europe in other categories | United States | Bausch + Lomb | registered |
| FUJIFILM Healthcare Americas Corporation Present in Europe in other categories | United States | FUJIFILM Stiffening Wire (SW-2000) | K251204 (2025) |
| Isolux, LLC | United States | OptiLux LED Illuminator | K163185 (2016) |
| OrbusNeich Medical (ShenZhen) Co., Ltd. | – | Jade PTA Balloon Dilatation Catheter | registered |
| PREMIER DENTAL PRODUCTS COMPANY | United States | Premier Jackson Improved Short Tracheostomy Tube | registered |
| STRATEGIC SOURCING SERVICES LLC | – | HealthMart | registered |
| TRANZONIC COMPANIES, THE | – | ProWorks | registered |
| ANDA Medical | Canada | – | registered |
| ARTHREX, INC. Present in Europe in other categories | United States | – | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | – | registered |
| ATL Technology LLC | United States | – | registered |
| ATMOS MedizinTechnik GmbH & Co. KG Present in Europe in other categories | Germany | – | registered |
| Alton (Shanghai) Medical Instruments Co., Ltd. | China | – | K242635 (2025) |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. Present in Europe in other categories | China | – | registered |
| Avantis Medical Systems, Inc. Present in Europe in other categories | United States | – | K160356 (2016) |
| BEIJING FANXING GUANGDIAN MEDICAL TREATMENT EQUIPMENT CO LTD Present in Europe in other categories | China | – | registered |
| BODDINGTONS PLASTICS LIMITED | United Kingdom | – | K191330 (2020) |
| BPEndo, LLC | United States | – | K261587 (2026) |
| Biotec Biotecnologias de Centroamerica S.A. | Costa Rica | – | registered |
| BriteMED Technology Inc. Present in Europe in other categories | Taiwan | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CHG-MERIDIAN CANADA LTD | Canada | – | registered |
| COGENTIX MEDICAL, INC. Present in Europe in other categories | United States | – | registered |
| COMMAND MEDICAL PRODUCTS, LLC | United States | – | registered |
| Carl Zeiss Meditec AG (Jena) Present in Europe in other categories | Germany | – | registered |
| Cook, Inc. | United States | – | registered |
| Cordica Medical (Formally Team Technologies, Inc) | United States | – | registered |
| DIMEDA INSTRUMENTE GMBH | Germany | – | registered |
| DJ Acquisition FTT, LLC | United States | – | registered |
| Daichuan Medical (Shenzhen) Co., Ltd | China | – | registered |
| Dalian Create Medical Products Co., LTD. | China | – | registered |
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