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Emdyca

Bioimaging and radiotherapy instrumentsVarious bioimaging and radiotherapy instrumentsBone densitometry systems

X-ray bone densitometers

EMDN code Z11900103

7 manufacturers, 16 models including 16 on the market, 5 countries

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Manufacturers registered in Europe (EUDAMED) 7
  • 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
Eurotec Medical Systems Italy IIb MDR Website info@eurotec-ms.com EUDAMED record Report an error
Ge Medical Systems Ultrasound Primary Care Diagnostics FDA EU representative : GE Medical Systems SCS (France) United States IIb MDR, 93/42 eudamed@gehealthcare.com EUDAMED record Report an error
OsteoSys EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea IIb MDR Website EUDAMED record Report an error
Stratec Medizintechnik FDA Germany IIb 93/42 info@stratec-med.com EUDAMED record Report an error
Apelem FDA France IIb MDR regulatory@dms-imaging.com EUDAMED record Report an error
medical ECONET Germany IIb 93/42 Website info@medical-econet.com EUDAMED record Report an error
Medikors EU representative : Javitech Consulting GmbH (Germany) South Korea IIb 93/42 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) 20

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
Mindways Software, Inc. Present in Europe in other categories United States QCT PRO Asynchronous 3D Spine and CTXA-Hip System QCT PRO Asynchronous 3D Spine Software QCT PRO 3D Volumetric Spine and CTXA Hip Software QCT PRO 3D Volumetric Spine Software CTXA Hip Extended Reference Data QCT PRO 3D Volumetric Spine System K140342 (2014)
Medimaps Group SA Present in Europe in other categories Switzerland TBS iNsight Phantom K243218 (2025)
Hologic, Inc. Present in Europe in other categories United States Horizon C Horizon W Horizon Wi Horizon A Horizon Ci K130277 (2013)
3D-Shaper Medical S.L Present in Europe in other categories Spain 3D-SHAPER K251022 (2025)
O N DIAGNOSTICS LLC United States VirtuOst K220402 (2023)
Block Imaging SAS United States – registered
BunkerHill Health United States – K242295 (2025)
Can Technomed Trading LTD. Canada – registered
Curvebeam AI / Curvebeam, LLC United States – K254072 (2026)
EverX / Bindra Australia – registered
FUJITA CO., LTD. Japan – registered
Flextronics International USA, Inc. United States – registered
GE HealthCare Technologies Inc. Present in Europe in other categories United States – registered
General Commerce & Trade, S.A. de C.V. Mexico – registered
HeartLung Corporation United States – K213760 (2022)
LJ Business Corporation Japan – registered
Makar Consulting Pty Ltd Australia – registered
MedSource Parts, LLC United States – registered
Medivest Group United Kingdom – registered
Siemens Healthineers AG Present in Europe in other categories Germany – registered

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