Instruments for functional explorations and therapeutic interventionsENT instrumentsVarious ENT instruments

Direct outpatient otoscopes

EMDN code Z12149006

31 manufacturers, 62 models including 62 on the market, 9 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 31

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.

Manufacturer	Country	Registered models	Class	Contact
Heine FDA	Germany	BETA 200 LED2 refs BETA 200 LED F.O. OTO.+ 4TIPS BETA OTOSCOPE + 4TlPS3 refs BETA 200 LED F.O. OTO./BETA HA.2 refs BETA 200 LED OTO./4 NT BETA LED OTO./4 NT2 refs BETA 200 LED OTO./4 USB+TR. BETA LED OTO./4 USB+TR.2 refs 15 others BETA 200 LED OTO.SET/4 NT BETA OTOSKOP SET/4 NT2 refs BETA 200 LED OTO.SET/4 USB+TR. BETA OTO. SET/4 USB+TR2 refs BETA 200 LED OTOSC.SET+BETA2 refs BETA X BETA X OTOSCOPE 3X2 refs K180 LED K180 LED F.O. OTO.+ 4 TIPS K180 F.O. OTOSCOPE + 4TlPS2 refs K180 LED OTO. SET/4 USB+TR. K180 LED OTOSCOPE SET+BETA K180 LED OTOSCOPE/BETA HA. mini 3000 F.O. LED2 refs MINI 3000 LED OTO.+HANDLE+1 X TIPS MIN13000 OTO+HAN+TIPS2 refs MINI 3000 LED OTOSC. SET MINI3000 OTO+TIPS SET2 refs MINI 3000 LED OTOSC.HANDLE + TIPS MIN13000 OTO.+HANDLE+TIPS2 refs MINI3000 LED FO OT+RECH.HA1XT.	I MDR	Website info@heine.com EUDAMED record Report an error
Uamedsurgical EU representative : Yellow's medical instruments GmbH (Germany)	Pakistan	Fiber Optic Otoscope (Pocket Style) 500-10 Fiber Optical Otoscope (Pocket Style) 500-20 UAMED 500-60 UAMEDConventional (Plastic Head Otoscope) 500-40 UAMEDFiber Optic (Metal Otoscope) 500-30	I MDR	Website info@uamedsurgical.com EUDAMED record Report an error
Clearwax EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	CLEARscope iCLEARscope kit WAXscope WAXscope kit	I MDR	info@clearwax.co.uk EUDAMED record Report an error
Firefly Global FDA EU representative : MDSS GmbH (Germany)	United States	DE500 DE508 DE550 DE570	I MDR	Website sales@fireflyglobal.com EUDAMED record Report an error
BMED	Italy	BONTEMPI - AB-32 - OTOSCOPIO CON 3 SPECULUM E ASTUCCIO OFTALMOSCOPI93/42 BONTEMPI - AB-49 - OTOSCOPIO A LUCE ALOGENA COMPLETO OFTALMOSCOPI93/42	I 93/42	Website EUDAMED record Report an error
Luxamed FDA	Germany	Otoscope smartled luxamed SPENGLER bronze3 refs wall diagnostic center with otoscope2 refs	I MDR	Website info@luxamed.de EUDAMED record Report an error
Aiesi	Italy	OTOSCOPIO VETERINARIO CON ILLUMINAZIONE LED2 refs	I MDR	COMMERCIALE@AIESI.IT EUDAMED record Report an error
Albertnovosino FDA EU representative : Sungo Cert GmbH (Germany)	China	OS801, OS802, OS803, OS804, OS805, OS806, OS807, OS808, OS809, OS810, OS811, OS812, OS813, OS814, OS816, OS817, OS818, OS819, OS820, OS821, OS826, OS828, OS830	I MDR	EUDAMED record Report an error
American Diagnostic FDA EU representative : S.C. Cattus S.R.L. (Romania)	United States	Diagnostix™2 refs	I MDR	Website info@adctoday.com EUDAMED record Report an error
Centralsurgical FDA EU representative : KHANG BAO INTERNATIONAL KFT (Hungary)	Pakistan	Otoscope Set	I MDR	Website EUDAMED record Report an error
Chin Kou Medical Instrument FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Taiwan	Fibre Diagnostic Otoscope CK-9383 refs	I MDR	Website info@spiritmedical.com.tw EUDAMED record Report an error
D-SAM International EU representative : CS Active (Latvia)	Pakistan	Disposable Speculas for Standard Otoscope Con Blk PP, 2.5mm 5203-13 refs	I MDR	Website info@dsamintel.com EUDAMED record Report an error
GIMA	Italy	"P16" OTOSCOPIO SIGMA LED F.O. con manico ricaricabile e batteria - in3 refs	I MDR	Website EUDAMED record Report an error
Gimmi FDA	Germany	AlphaScope™3 refs	I MDR	Website EUDAMED record Report an error
GM Instruments FDA EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Otoscope AC300-OTS	I MDR	Website EUDAMED record Report an error
Henke-Sass, Wolf FDA	Germany	OTOSCOPES3 refs	I MDR	Website EUDAMED record Report an error
Honsun (Nantong) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Otoscope HS-OT10G3 refs	I MDR	EUDAMED record Report an error
Keeler FDA EU representative : Keeler Europe Distribution, S.L. (Spain)	United Kingdom (ex Northern Ireland)	2.8V POCKET OTO IN CASE3 refs	I MDR	Website regulatory@keeler.co.uk EUDAMED record Report an error
MedRx FDA EU representative : DGS Diagnostics A/S (Denmark)	United States	MedRx Video Otoscope	I MDR	Website quality@medrx-diagnostics.com EUDAMED record Report an error
Natus FDA	Denmark	OTOSCAN3 refs	I MDR	Website EUDAMED record Report an error
Satellite EU representative : International Business Compendious of Sweden (Sweden)	Pakistan	Otoscopes TOC-106-003BL	I MDR	EUDAMED record Report an error
SG Manufacturers FDA EU representative : International Business Compendious of Sweden (Sweden)	Pakistan	Otoscope FMO-001-8800-1095.01R	I MDR	Website sales@sgminstruments.com EUDAMED record Report an error
Sibbo Medical Devices	Finland	Sibbo Loupe	I MDR	Website info@sibbomedicaldevices.com EUDAMED record Report an error
STEMA Medizintechnik	Germany	Otoscopes LA-000-0013 refs	I MDR	Website info@stema-medizintechnik.de EUDAMED record Report an error
Surtex Instruments FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United Kingdom (ex Northern Ireland)	Apollo PLUS Fiber Optic Universal EENT Diagnostic Set Complete Including 1 x Otoscope Head, 1 x Ophthalmoscope Head, 1 x Battery Handle, 1 x Nasal Illuminator, 1 x Straight Illuminator, 1 x Plain Mirror 20 mm, 1 x Tongue Depressor 50554459DIAGNOSTI149006J23 refs	I MDR	Website info@surtex-instruments.co.uk EUDAMED record Report an error
Tianjin Bolang Science-Technology Development EU representative : Lotus NL B.V. (Netherlands)	China	Otoscope ER023 refs	I MDR	EUDAMED record Report an error
Tonglu Sike Medical Instrument EU representative : endodoctor GmbH (Germany)	China	EJ2001, EJ2001A, EJ2002, EJ2003, EJ2003A, EJ2004, EJ2005, EJ2006, EJ2007, EJ2008, EJ2009, EJ2010, EJ2011, EJ2012, EJ2013, EJ2014, EJ2015, EJ2016, EJ2017, EJ2018, EJ2019, EJ2020, EJ2021, EJ2022, EJ2023, EJ2024, EJ2025, EJ20263 refs	I MDR	EUDAMED record Report an error
Tympahealth FDA EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Charging Standard (iPhone 13)3 refs	I MDR	Website QARA@tympahealth.com EUDAMED record Report an error
Wudao Pu (Shenzhen) Technology EU representative : Debao International GmbH (Germany)	China	Earwax removal and ear examination tools P13,P10,P12,P15,P50,P80,P90,N18,N19,N20,N213 refs	I MDR	EUDAMED record Report an error
Zhejiang Honsun Medical Technology FDA EU representative : Sungo Cert GmbH (Germany)	China	HS-OT10,HS-OT10A,HS-OT10B,HS-OT10C, HS-OT10D,HS-OT10E,HS-OT10F, HS-OT10G,HS-OT10H,HS-OT10I, HS-OT10J,HS-OT10K,HS-OT10L, HS-OT10L-C,HS-OT10L-C2,HS-OT10M, HS-OT10N, HS-OT10P,HS-OT10Q, HS-OT10R,HS-OT10S,HS-OT10T, HS-OT10U,HS-OT10W,HS-OT10X, HS-OT10Y,HS-OT10Z	I MDR	EUDAMED record Report an error
Zhejiang New Vision Imp. & Exp EU representative : REP Europe GmbH (Germany)	China	PSN20002	I MDR	sales@paission.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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