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Emdyca

Bioimaging and radiotherapy instrumentsEchography instrumentsUltrasound scanners

Ultrasound scanners - hardware accessories

EMDN code Z11040180

12 manufacturers, 80 models including 48 on the market, 5 countries

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Manufacturers registered in Europe (EUDAMED) 12
  • 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
Sonosite FDA EU representative : Fujifilm Sonosite B.V. (Netherlands) United States
53 others
I, IIa MDR, 93/42 Website EUDAMED record Report an error
Olympus FDA EU representative : Olympus Europa SE & Co. KG (Germany) Japan
2 others
I, IIa MDR, 93/42 EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) Japan I MDR EUDAMED record Report an error
Konica Minolta FDA EU representative : Konica Minolta Business Solutions Europe GmbH (Netherlands) Japan I MDR EUDAMED record Report an error
Philips FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands) United States I MDR eudamed@philips.com EUDAMED record Report an error
Arjo FDA Sweden IIa MDR Website info@arjo.com EUDAMED record Report an error
Bard Access Systems FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States I MDR EUDAMEDenquiries@bd.com EUDAMED record Report an error
Capintec FDA EU representative : Atlantico Systems, Ltd. (Ireland) United States I MDR Website EUDAMED record Report an error
EchoNous FDA EU representative : Advena Limited (Malta) United States I MDR Website info@echonous.com EUDAMED record Report an error
Insight Lifetech EU representative : MedNet EC-REP C III GmbH (Germany) China I MDR EUDAMED record Report an error
Northh FDA Germany IIa MDR Website EUDAMED record Report an error
Siemens Medical Solutions USA FDA EU representative : Siemens Healthcare s.r.o. (Slovakia) United States IIa MDR Website contact@siemens-healthineers.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) 21

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
HOYA CORPORATION United States PENTAX PENTAX Medical registered
Boston Scientific Corp Present in Europe in other categories United States Expect Slimline SL Expect iNod™ Acquire Acquire™ S iNod™ Ultrasound Guidance Conso K260428 (2026)
Micro-Tech (Nanjing) Co., Ltd. China Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) K212852 (2021)
Endosound, Inc. United States EndoSound® EVS™ Band Applicator EndoSound® EVSScanner EndoSound® EVS™ Bands EndoSound® Transducer Extension Connector (TEC) EndoSound® Coax Transducer Extension Connector (TEC) EndoSound® Ultrasound Disposable Kit (UDK-T) 5008 K232518 (2023)
Pentax of America, Inc. Present in Europe in other categories United States ULTRASOUND GASTROSCOPE K203166 (2020)
Cook, Inc. United States EchoTip ClearCore EchoTip AcuCore registered
US Endoscopy United States Ultramatrix registered
Sonoscape Medical Corp. Present in Europe in other categories China SonoScape K231813 (2024)
APEX MEDICAL TECHNOLOGIES, INC. Present in Europe in other categories United States – registered
Adroit USA Inc United States – registered
Fuji Latex Co., LTD. Japan – registered
HOYA Corporation PENTAX Division United States – registered
Ian Jamieson Pty Ltd Australia – registered
NZ Biomed Limited New Zealand – registered
OMERIN CABLES SAS France – registered
Onepass Medical , Ltd. Israel – K251542 (2025)
PROBO Medical SAS France – registered
STERIS Corporation Present in Europe in other categories United States – registered
Sanicure BV Netherlands – registered
United States Endoscopy Group, Inc. (Us Endoscopy) Present in Europe in other categories United States – K180731 (2018)
Worldwide Supplies Limited Hong Kong SAR China – registered

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