Instruments for functional explorations and therapeutic interventions
ENT instruments
EMDN code Z1214
Manufacturers registered in Europe (EUDAMED) 83
- 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) 391
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 |
|---|---|---|---|
| Grason & Associates LLC | United States | Grason & Associates, LLC | registered |
| Amico Diagnostic Incorporated Present in Europe in other categories | United States | Amico Diagnostic Station Amico Diagnostic Wallboard Amico Diagnostic Rollstand Amico Diagnostic Otoscope Amico Diagnostic Aneroid | registered |
| Etymotic Research | United States | Etymotic Single Use Eartip Etymotic Research ER-2 Lucid Hearing ® | K150491 (2015) |
| Rudolf Riester GmbH & Co. KG | Germany | RVS-200, NIBP(Riester) +SpO2(Riester) + Pred. Temp EliteVue oto/ophthal. L2 set ,XL, 2.5V, with e-scope® otoscope, direct illumination, XL 2.5 V, e-scope® F.O. otoscope XL 2.5V, white, EliteVue otoscope set, LED, 3.5V, with C-handle, 1 EliteVue oto/ophthal. set,LED,3.5V,with 2C-handles | K950913 (1995) |
| Jedmed Instrument Co. | United States | JEDMED | K953457 (1995) |
| CADWELL INDUSTRIES, INC. Present in Europe in other categories | United States | Cadwell Guardian Sierra Summit Easy III Cascade Cascade IOMAX Intraoperative Monitor Sierra Summit/Ascent | registered |
| Prosidio LLC | United States | Prosidio | registered |
| Intl. Medical, Inc. | United States | BV Medical KaWe | registered |
| GE Healthcare Finland Oy Present in Europe in other categories | Finland | CARESCAPE CARESCAPE B850 CARESCAPE B450 CARESCAPE B650 CARESCAPE Software | registered |
| Ws Audiology Usa, Inc. | Canada | REAL-EAR Auditdata A/S | registered |
| BR Surgical, LLC | – | BR Surgical, LLC | registered |
| DETAX GmbH | Germany | easy impression syringe violet easy impression syringe green mixing cannulas optima white 50 pcs 6mm mixing Tips minimix green, 25 pcs mixing cannulas optima white 100 pcs 6mm mixing cannulas Automix pink 6mm 100 pcs | registered |
| Eb Neuro S.P.A. Present in Europe in other categories | United States | NeMus 1 NeMus 2 NExT-AS NeMus 2 700 NExT Station Advanced NeMus SYSTEM | registered |
| Welch Allyn, Inc. Present in Europe in other categories | United States | Welch Allyn, Inc. | K861516 (1986) |
| Zumax Medical Co., LTD Present in Europe in other categories | China | zumax | registered |
| Medical Technology Industries, Inc. | United States | MTI | registered |
| Lina Medical Aps Present in Europe in other categories | Denmark | Meniett™ Earplug, Green, 14 mm Meniett™ Earplug, Blue, 16 mm Meniett™ Power Cord, Continental Europe Meniett™ Power Cord, North America Meniett ® Pulse Generator- LOANER Meniett™ Power Cord, Australia and New Zeland | registered |
| Diagnostic Group LLC | United States | Grason-Stadler | K092244 (2010) |
| MEDTRONIC PS MEDICAL, INC. | United States | EXTERNAL DRAINAGE MONITORING Becker | registered |
| SONTEC INSTRUMENTS, INC. | United States | EN100 TL HANDLE EXTRA CORD EN50 BASE UNIT MPACK MINATURE BELT CLIP LED PLUG IN TRANSFORMER MPACK | registered |
| Ecleris | United States | OTOSCOPE VNG 3D | registered |
| INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories | United States | Integra® Jarit® Integra® Miltex® Integra® | registered |
| C F M TECHNOLOGIES INC | – | CFM Technologies ENT POCKET LIGHT | registered |
| Kirchner & Wilhelm GmbH + Co KG Present in Europe in other categories | United States | BASIC-SET COMBILIGHT C10/E10 ophthalmoscope and otoscope EUROLIGHT C10 otoscope with screw closure system COMBILIGHT C10 otoscope with plastic head, 2.5 V PICCOLIGHT F.O. LED standard, otoscope, stone PICCOLIGHT C otoscope, stone with ear funnels, cloth bag EUROLIGHT C10/E10 SET ophthalmoscope and otoscope | registered |
| zebris MEDICAL GmbH | Germany | FDM-SX FDM-2 FDM-3 FDM-2 System FDM-1.5 System FDM-1.5 | registered |
| LSL Industries, LLC | – | LSL HEALTHCARE | registered |
| NOVO SURGICAL, INC. | – | Novo Surgical Novo Surgical Inc. | registered |
| STERIS Corporation Present in Europe in other categories | United States | V. Mueller | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| PRECISION CAST PLASTIC PARTS, INC. | United States | Precision Probe Tubes | registered |
| Shenzhen Teslong Technology Co.,Ltd | – | Otoscope walgreens | registered |
| Bear-Ent, LLC | United States | BEAR | registered |
| EMOYODOTNETZA (PTY) LTD | – | KUDUwave | registered |
| MEDTRAK VNG, INC. | United States | MedTrakVNG MobiTrak System MobiTrakVNG Receiver MedTrakVNG Footswitch MedTrakVNG Interface Controller MedTrakVNG Goggle MobiTrak Software v3.00 | registered |
| Nuance Medical, LLC | United States | EarClear Rx | registered |
| Ototronix, LLC | United States | Otogram | registered |
| AMBCO ELECTRONICS | – | AMBCO | registered |
| Bausch & Lomb, Inc. Present in Europe in other categories | United States | Bausch + Lomb | registered |
| Benson Medical Instruments Co. | United States | Benson Medical Instruments Co. | K982441 (1998) |
| DOREL JUVENILE GROUP, INC. | United States | Safety 1st | registered |
| Etymonic Design, Inc. | Canada | Audioscan Audioscan Probe Tube Verifit Skull Simulator | K012306 (2001) |
| Examinetics, Inc. | United States | Salux™ | registered |
| Frye Electronics, Inc. | United States | Fonix HearLab | K123701 (2013) |
| Gobiquity, Inc. | United States | GoCheck Audiometric Headphone Assembly GoCheck MultiScreener GoCheck | registered |
| M.R.S. SRL | Italy | Resonance | registered |
| SPORT MEDICAL TECHNOLOGY INC. Present in Europe in other categories | United States | BALANCE SD BIOSWAY VibroTactile | registered |
| U.S. OPHTHALMIC, L.L.C. | United States | Eli Ezer | registered |
| Haag-Streit AG Present in Europe in other categories | Switzerland | Reliance | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | registered |
| N K I | – | I-Portal Super VNG I-Portal Portable Assessment System Neuro Kinetics Inc | registered |
| NORTH AMERICAN RESCUE, LLC | United States | NAR | registered |
| SCHÖLLY FIBEROPTIC GmbH Present in Europe in other categories | Germany | PrimeSight | registered |
| Vestibular First | United States | Vestibular First | K203082 (2020) |
| Wavely Diagnostics, Inc. | United States | WavelyDx Ear Tip - Pack of 6 WavelyDx Ear Tip - Pack of 3 WavelyDx Ear Tip - Pack of 2 WavelyDx Middle Ear Fluid CMD iOS Application | registered |
| Heifeng Zhizao(Shenzhen)Technology Co.,Ltd | China | BEBIRD | registered |
| KINVENT BIOMECANIQUE Present in Europe in other categories | France | KForce Plates KForce Deltas KForce Deltas XL | registered |
| Micro Audiometrics Corp. | United States | Earscan 3 | K982878 (1998) |
| Micromedical Technologies, Inc. | United States | Micromedical Technologies | K964646 (1997) |
| NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | United States | AED | registered |
| NEUROSOFT, OOO | – | Neuro-Audio Neuro-IOM | registered |
| NONAGON LTD | Israel | Nonagon N9+ SmartExam Nonagon N9+ Nonagon | registered |
| Spryson America, Inc. | United States | Neurolign Dx NOTC Neurolign Dx SVNG Neurolign Dx100 | registered |
| Synapsys, Inc. | United States | Complete Monocular wireless Smart Cam system with Goggles Flex Complete Monocular wireless Smart Cam system with Xpress mask Kinetic Wi-Fi wireless VNG Ulmer system with Goggles Flex | K163558 (2017) |
| WAVI CO. | United States | WAVi Scan Kit WAVi Electrical Processing Unit WAVi Scan Software | registered |
| WESTERN SYSTEMS RESEARCH INC. | United States | ENGplus™ VAT® MotionTrak | K010059 (2001) |
| Balance Tracking Systems Incorporated | United States | Assess Balance BTrackS Balance Plate | registered |
| Concordance Healthcare Solutions LLC | – | HCS | registered |
| ELMED INCORPORATED | United States | ELMED | registered |
| Firefly Neuroscience, Inc. | United States | Evoke EEG System Evoke EEG System Amplifier | registered |
| Forward Science Technologies LLC | – | FS Dispenser FS Dispenser, Stainless | registered |
| GF HEALTH PRODUCTS, INC. Present in Europe in other categories | United States | LABTRON Grafco | registered |
| Jacoti | – | Jacoti Hearing Center Jacoti Hearing Center Pro | registered |
| KINVENT HELLAS | Greece | KINVENT | registered |
| Med Saver, Inc. | – | MSI Precision Specialty Instruments | registered |
| Ningbo Tealmed Emergency Products Co., Ltd. | – | Tealmed | registered |
| OPCOM INC. | Taiwan | Penguin ENT Scope model | registered |
| SHOEBOX Ltd | – | SHOEBOX Audiometry | registered |
| VESTIBULAR TECHNOLOGIES, LLC | – | CAPS | registered |
| VIRTUALIS | France | StaticVR MotionVR | registered |
| WAHTS HEARING LLC | United States | WAHTS Audhere Software | registered |
| WALGREEN CO. | – | Walgreens | registered |
| BTS SPA Present in Europe in other categories | Italy | P6000 | registered |
| Be Bird Usa, Inc | – | bebird | registered |
| DIERS International GmbH Present in Europe in other categories | Germany | DIERS pedogait | registered |
| Db Diagnostic Systems, Inc. | United States | Healing Healthcare Pro | K183201 (2019) |
| Devilbiss Health Care, Inc. Present in Europe in other categories | United States | DeVilbiss | registered |
| Diversified Healthcare Development, LLC | United States | Koresway | registered |
| EQUIDOR MEDTECH LLP | – | EQUIPOISE | registered |
| Frontier Dental Supply Inc | – | House Brand Dentistry | registered |
| Glottal Enterprises, Inc. | United States | Two Channel Electroglottograph EG2-PCX2 | registered |
| ILO electronic GmbH Present in Europe in other categories | Germany | ILO | registered |
| INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C. | United States | IEC-Innoview GmbH | registered |
| ISEN Tech. & Trading Co., Ltd. | China | ISEN-Goggles | K152727 (2016) |
| K.T.SURGICO | Pakistan | K.T.Surgico | registered |
| MEDTRONIC XOMED, INC. Present in Europe in other categories | United States | MENIETT® | registered |
| Medeia, Inc. Present in Europe in other categories | United States | BrainView NeuralScan | registered |
| NEUROSYNC INC. | United States | EYE-SYNC | registered |
| NORTH EOS INDUSTRIES INC. Present in Europe in other categories | Taiwan | EOS | registered |
| Righteye, LLC | United States | RightEye Vision System | K181771 (2018) |
| Smith & Nephew, Inc. Present in Europe in other categories | United States | Journey II | registered |
The 100 most active manufacturers are shown, out of 391.
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- Parent category : Instruments for functional explorations and therapeutic interventions3,039 manufacturers