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Emdyca

Instruments for functional explorations and therapeutic interventionsENT instrumentsVarious ENT instruments

Impedance meters for the auditory system

EMDN code Z12149005

9 manufacturers, 16 models including 15 on the market, 4 countries

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Manufacturers registered in Europe (EUDAMED) 9
  • 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
Amplivox FDA EU representative : DGS Diagnostics A/S (Denmark) United Kingdom (ex Northern Ireland) IIa MDR Website info@amplivox.com EUDAMED record Report an error
Inventis FDA Italy IIa MDR Website quality@inventis.it EUDAMED record Report an error
G. Heinemann Medizintechnik Germany IIa 93/42 Website info@heinemann-ent.de EUDAMED record Report an error
Natus FDA Denmark I, IIa MDR Website EUDAMED record Report an error
BioMed Jena Germany IIa 93/42 Website eudamed@biomed-jena.de EUDAMED record Report an error
Interacoustics FDA Denmark IIa MDR Website info@interacoustics.com EUDAMED record Report an error
Neuranix Italy IIa MDR Website info@neuranix.com EUDAMED record Report an error
Pathme FDA Germany IIa MDR Website info@pathme.de EUDAMED record Report an error
Maico FDA No model still on the market Germany IIa MDR Website info@maico.biz 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) 13

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
Welch Allyn, Inc. Present in Europe in other categories United States Welch Allyn, Inc. K861516 (1986)
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
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
Diagnostic Group LLC United States Grason-Stadler registered
M.R.S. SRL Italy Resonance registered
Db Diagnostic Systems, Inc. United States Healing Healthcare Pro K183201 (2019)
MEDTRONIC XOMED, INC. Present in Europe in other categories United States MENIETT® registered
Asicomo A/S Denmark – registered
Baxter Healthcare Corp Present in Europe in other categories United States – registered
DEMANT A/S Denmark – registered
Gn Otometrics United States – K161707 (2016)
PATH Germany – registered
VEENAK INTERNATIONAL LIMITED United Kingdom – registered

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