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Emdyca

Instruments for functional explorations and therapeutic interventionsENT instrumentsVarious ENT instruments

Various ENT instruments - consumables

EMDN code Z12149085

8 manufacturers, 14 models including 14 on the market, 6 countries

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Manufacturers registered in Europe (EUDAMED) 8
  • 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.
ManufacturerCountryRegistered modelsClassContact
Gyrus ACMI FDA EU representative : Olympus Europa SE & Co. KG (Germany) United States IIa 93/42 EUDAMED record Report an error
Dgs Diagnostics A S Denmark I MDR ra_product-lifecycle@dgs-diagnostics.com EUDAMED record Report an error
Besdatatech FDA EU representative : SUNGO Europe B.V. (Netherlands) China I MDR support@besdatatech.com EUDAMED record Report an error
Comed France I MDR Website commercial@comed.fr EUDAMED record Report an error
Hammarplast Medical FDA Sweden I MDR Website info@hpm.se EUDAMED record Report an error
Nanjing Ihome Comfort EU representative : Sungo Cert GmbH (Germany) China I MDR EUDAMED record Report an error
Tyto Care FDA EU representative : MedNet EC-REP GmbH (Germany) Israel I MDR Website info@tytocare.com EUDAMED record Report an error
Welch Allyn FDA EU representative : Welch Allyn Limited (Ireland) United States 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.

Other manufacturers known in the United States (FDA) 11

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.

ManufacturerCountryBrandsFDA clearance
Natus Medical Denmark ApS Present in Europe in other categories Denmark GN Otometrics A/S Natus registered
Interacoustics A/S Present in Europe in other categories Denmark Sanibel Supply A/S Interacoustics 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)
Etymonic Design, Inc. Canada Audioscan Audioscan Probe Tube Verifit Skull Simulator K012306 (2001)
Etymotic Research United States Etymotic Research K861113 (1986)
INVENTIS SRL Present in Europe in other categories Italy TRUMPET DRUM registered
MEDRX, INC. Present in Europe in other categories United States MedRx registered
Frye Electronics, Inc. United States Fonix K093006 (2009)
DEMANT A/S Denmark – registered
Natus Medical Incorporated Present in Europe in other categories United States – registered
WSAUD A/S Denmark – registered

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