Instruments for functional explorations and therapeutic interventionsENT instruments

Audiometers

EMDN code Z121401

24 manufacturers, 85 models including 85 on the market, 12 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 24

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
Natus FDA	Denmark	1052 Otosuite Accessory 1066 Astera2 Accessories - Audiometer Control Panel (ACP)2 refs 1066 Astera2 Accessories - Headphones 1066 Astera2 Accessories - Insert Earphones 1066 Astera2 Accessories - Software 10 others 1066 MADSEN Astera 23 refs 1081 Aurical Aud3 refs 1081 Madsen A4503 refs AURICAL Loudspeaker 8‑62‑45200 Bone Conductor2 refs Foam Ear Tips 80A48209003 refs HB‑8 Headband (8 kHz) 8‑75‑4302 refs Headset ME70 (12 kHz) 8-75-7902 refs Headset ME70 (8 kHz) 8‑75‑770 Patient Responder3 refs	I, IIa MDR	Website EUDAMED record Report an error
Maico FDA	Germany	easyDigits easyTone MA 1 MA 25 MA 27 5 others MA 28 MA 33 MA 42 PILOT TEST RA660	IIa MDR	Website info@maico.biz EUDAMED record Report an error
Amplivox FDA EU representative : DGS Diagnostics A/S (Denmark)	United Kingdom (ex Northern Ireland)	Anova Model 116 Model 170 Model 240 Model 260 4 others Model 2702 refs modelONE Otosure PC850	IIa MDR	Website info@amplivox.com EUDAMED record Report an error
Interacoustics FDA	Denmark	Interacoustics AC40 Interacoustics AD226 Interacoustics AD528 Interacoustics AD629 Interacoustics AS608 4 others Interacoustics Callisto Interacoustics Equinox Evo Interacoustics Luna Interacoustics PA5	IIa MDR	Website info@interacoustics.com EUDAMED record Report an error
BHM-Tech Produktionsgesellschaft m.b.H FDA	Austria	BC-1-BONE-W-HEADBAND/GR702493/42 BC-1-BONE-W-HEADBAND/SET/GR702493/42 BC-1/GR702493/42 BC-2LD-BONE-W-BC-1-HEADBAND-SET/GR702493/42 BC-2LD-BONE-W-NB72-HEADBAND-SET/GR702493/42 1 other BC-2LD/GR702493/42	IIa 93/42	Website info@bhm-tech.com EUDAMED record Report an error
MedRx FDA EU representative : DGS Diagnostics A/S (Denmark)	United States	Avant A2D+ Avant AIR+ Avant ARC MedRx AWRC MedRx Kiosk	IIa MDR	Website quality@medrx-diagnostics.com EUDAMED record Report an error
Sibel Sau	Spain	Sibelsound 400 A3 refs Sibelsound DUO A2 refs Sistema Sibelsound 400 A3 refs Sistema Sibelsound DUO A2 refs Software W50	IIa MDR	Website EUDAMED record Report an error
Inventis FDA	Italy	Bell Basic2 refs Harp Basic Piano Basic Piccolo Basic3 refs	IIa MDR	Website quality@inventis.it EUDAMED record Report an error
Pathme FDA	Germany	Infant Ear Tip 3.5mm ET-IP10mm3 refs Live speech microphone MIC-013 refs Senti Desktop SOH100098	I, IIa MDR	Website info@pathme.de EUDAMED record Report an error
Amplifon FDA	Italy	OtoKiosk OtoPad	IIa MDR	Website EUDAMED record Report an error
Auditdata FDA	Denmark	Entomed SA201 SA 201, SA202, SA203, SA2043 refs Primus Ice 2000-1 Fitting Unit - Unity 4, Measure, 2000 Primus Pro, Ice, PFU+3 refs	IIa MDR	Website compliance@auditdata.com EUDAMED record Report an error
Merz Medizintechnik	Germany	MERZ AM-4 Audiometrie-Lautsprecher 510500053 refs MERZ IEP2-10 Einsteckhörer 610006002 refs	I, IIa MDR	Website EUDAMED record Report an error
PISTON Műszaki Fejlesztő, Kereskedelmi és Ügynöki Korlátolt Felelősségű Társaság	Hungary	PC based screening audiometer PDD-40193/42 PDD-40193/42	IIa 93/42	Website info@pistonmedical.com EUDAMED record Report an error
Auritec	Germany	AT-research Tone- and Speech-Audiometer2 refs	IIa MDR	EUDAMED record Report an error
BioMed Jena	Germany	eAUDIO USB93/42	IIa 93/42	Website eudamed@biomed-jena.de EUDAMED record Report an error
Evertone EU representative : MedNet EC-REP GmbH (Germany)	Australia	Evertone Auris	IIa MDR	Website EUDAMED record Report an error
FIM Medical FDA	France	Audiolyser® ADL Connect DD65V2	IIa MDR	Website contact@fim-medical.com EUDAMED record Report an error
Hearx Pty FDA EU representative : Advena Limited (Malta)	South Africa	hearTest	IIa MDR	Website compliance@hearxgroup.com EUDAMED record Report an error
Hörzentrum Oldenburg gGmbH	Germany	Oldenburger Mesprogramme2 refs	IIa MDR, 93/42	Website info@hz-ol.de EUDAMED record Report an error
Koalys EU representative : AR Experts B.V. (Netherlands)	Israel	Koalys Consult93/42	IIa 93/42	Website contact@koalys.com EUDAMED record Report an error
Oscilla FDA	Denmark	Oscilla ® A50 DD65 headset ATM43 refs	IIa MDR	Website info@oscilla.dk EUDAMED record Report an error
Otopront FDA	Germany	Aures Center4 refs93/42	IIa 93/42	Website info@otopront.de EUDAMED record Report an error
Widex A S	Denmark	ACC. SERVICE LINK CONN PROGRAMMING93/42	IIa 93/42	Website EUDAMED record Report an error
Zeisberg	Germany	CA350 T24013 refs	I MDR	Website 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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