Instruments for functional explorations and therapeutic interventionsENT instruments
Various ENT instruments
EMDN code Z121490
Manufacturers registered in Europe (EUDAMED) 52
- 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) 315
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) |
| Prosidio LLC | United States | Prosidio | registered |
| Intl. Medical, Inc. | United States | BV Medical KaWe | registered |
| Jedmed Instrument Co. | United States | JEDMED | K944031 (1994) |
| Ws Audiology Usa, Inc. | Canada | REAL-EAR Auditdata A/S | registered |
| Vivosonic, Inc. Present in Europe in other categories | Canada | Integrity OAE Probe Integrity Insert Earphones Integrity Amplitrode Integrity EP Headphones Integrity Bone Conductor Integrity V500 | K033108 (2003) |
| 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 |
| 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 |
| 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) |
| 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 |
| Ecleris | United States | OTOSCOPE | 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 |
| BR Surgical, LLC | – | BR Surgical, LLC | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| OPTOMIC ESPAÑA SA Present in Europe in other categories | Spain | Optomic | registered |
| PRECISION CAST PLASTIC PARTS, INC. | United States | Precision Probe Tubes | registered |
| Shenzhen Teslong Technology Co.,Ltd | – | Otoscope walgreens | registered |
| Auditdata A/S Present in Europe in other categories | Denmark | Primus By Auditdata Measure by Otometrics - HIT OTOPro By Auditdata Unity 3 | K113831 (2012) |
| Bear-Ent, LLC | United States | BEAR | registered |
| EMOYODOTNETZA (PTY) LTD | – | KUDUwave | registered |
| Nuance Medical, LLC | United States | EarClear Rx | registered |
| Oscilla A/S Present in Europe in other categories | Denmark | Oscilla | 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 |
| Gobiquity, Inc. | United States | GoCheck Audiometric Headphone Assembly GoCheck MultiScreener GoCheck | registered |
| M.R.S. SRL | Italy | Resonance | registered |
| U.S. OPHTHALMIC, L.L.C. | United States | Eli Ezer | registered |
| Frye Electronics, Inc. | United States | Fonix | K093006 (2009) |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | registered |
| NORTH AMERICAN RESCUE, LLC | United States | NAR | registered |
| SCHÖLLY FIBEROPTIC GmbH Present in Europe in other categories | Germany | PrimeSight | registered |
| 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 |
| Micro Audiometrics Corp. | United States | Earscan 3 | K982878 (1998) |
| NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | United States | AED | registered |
| NONAGON LTD | Israel | Nonagon N9+ SmartExam Nonagon N9+ Nonagon | registered |
| Concordance Healthcare Solutions LLC | – | HCS | registered |
| ELMED INCORPORATED | United States | ELMED | 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 |
| 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 |
| SONTEC INSTRUMENTS, INC. | United States | POMEROY EAR SYRINGE | registered |
| WAHTS HEARING LLC | United States | WAHTS Audhere Software | registered |
| WALGREEN CO. | – | Walgreens | registered |
| Amplifon S.P.A. Present in Europe in other categories | United States | OtoPad | K983915 (1999) |
| Be Bird Usa, Inc | – | bebird | 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 |
| 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 |
| K.T.SURGICO | Pakistan | K.T.Surgico | registered |
| KOALYS TECHNOLOGIES LTD Present in Europe in other categories | Israel | Audyx | registered |
| MEDTRONIC XOMED, INC. Present in Europe in other categories | United States | MENIETT® | registered |
| NEUROSOFT, OOO | – | Neuro-Audio | registered |
| NORTH EOS INDUSTRIES INC. Present in Europe in other categories | Taiwan | EOS | registered |
| WISC MED, LLC | United States | WiscMed | registered |
| WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | – | CVS | registered |
| wenzhou dongfang medical instrument co.,ltd | – | – | registered |
| AGAPLASTIC IND. COM. LTDA. | Brazil | – | registered |
| ALBERT HOHLKOERPER GMBH & CO. KG | Germany | – | registered |
| ALLIED HILL ENTERPRISES, LTD. | Hong Kong SAR China | – | registered |
| ALPS INTERNATIONAL | India | – | registered |
| AMBCO ELECTRONICS, A CALIFORNIA CORP. | United States | – | registered |
| ARI Medical Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| ASIA CONNECTION CO., LTD. | Taiwan | – | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | – | registered |
| ATMOS MedizinTechnik GmbH & Co. KG Present in Europe in other categories | Germany | – | registered |
| Ackermann Instrumente GmbH Present in Europe in other categories | United States | – | registered |
| Aesculap, Inc. Present in Europe in other categories | United States | – | registered |
| Alvi Expo | Pakistan | – | registered |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. Present in Europe in other categories | China | – | registered |
| Anqing Changfan Medical Instrument Co., Ltd | China | – | registered |
| Aoj Health Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| Apothecaries Sundries Mfg Pvt Ltd | India | – | registered |
| Arimon Technologies, Inc. | United States | – | registered |
| Armatech International | Pakistan | – | registered |
| Asicomo A/S | Denmark | – | registered |
| Audelation Present in Europe in other categories | United Kingdom | – | registered |
| Aurality Inc. | United States | – | registered |
| Avilign Medical | Pakistan | – | registered |
The 100 most active manufacturers are shown, out of 315.
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