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Emdyca

Bioimaging and radiotherapy instrumentsEchography instrumentsUltrasound scanners

Internal ultrasound scanners

EMDN code Z11040101

18 manufacturers, 67 models including 67 on the market, 6 countries

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Manufacturers registered in Europe (EUDAMED) 18
  • 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
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
4 others
 IIa MDR EUDAMED record Report an error
GE Ultrasound Korea EU representative : GE Medical Systems SCS (France) South Korea
4 others
 IIa MDR eudamed@gehealthcare.com EUDAMED record Report an error
Shenzhen Delica Medical Equipment FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
3 others
 IIa MDR, 93/42 quality@delicasz.com EUDAMED record Report an error
Ge Medical Systems Ultrasound Primary Care Diagnostics FDA EU representative : GE Medical Systems SCS (France) United States
2 others
 IIa MDR eudamed@gehealthcare.com EUDAMED record Report an error
Siemens Medical Solutions USA FDA EU representative : Siemens Healthcare s.r.o. (Slovakia) United States
2 others
 IIa MDR Website contact@siemens-healthineers.com EUDAMED record Report an error
GE Medical Systems FDA EU representative : GE Medical Systems SCS (France) China
1 other
 IIa MDR, 93/42 eudamed@gehealthcare.com EUDAMED record Report an error
Konica Minolta FDA EU representative : Konica Minolta Business Solutions Europe GmbH (Netherlands) Japan IIa MDR, 93/42 EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) Japan IIa MDR EUDAMED record Report an error
InnerMedical EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR contact@innermedical.com EUDAMED record Report an error
Sonoscape FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR ra@sonoscape.net EUDAMED record Report an error
Zoncare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR Website EUDAMED record Report an error
Aohua EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Bayoocare Germany IIb MDR Website info@bayoocare.com EUDAMED record Report an error
Beijing LepuImage Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
Exact Imaging FDA EU representative : Emergo Europe B.V. (Netherlands) Canada IIa MDR Website regulatory@exactimaging.com EUDAMED record Report an error
Hisense FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
PoroUS Germany IIa MDR Website info@porous.care EUDAMED record Report an error
Samsung FDA EU representative : Samsung Electronics GmbH (Germany) South Korea IIa MDR vigilance@samsung.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.

Other manufacturers known in the United States (FDA) 3

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
Novasignal Corp. United States NovaGuide™ Intelligent Ultrasound System NovaBot Automated Headset NovaKit Exam Pack (NovaKit) registered
NeuraSignal, Inc. United States – registered
Viasonix , Ltd. Present in Europe in other categories Israel – registered

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