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Emdyca

Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsVarious instruments for radiodiagnostics and interventional procedures

High voltage X-ray generators

EMDN code Z11039011

17 manufacturers, 44 models including 44 on the market, 8 countries

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Manufacturers registered in Europe (EUDAMED) 17
  • 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
Neusoftmedical FDA EU representative : Emergo Europe B.V. (Netherlands) China
3 others
IIb 93/42 EUDAMED record Report an error
medical ECONET Germany
2 others
IIb 93/42 Website info@medical-econet.com EUDAMED record Report an error
Philips FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands) China, Germany IIb MDR eudamed@philips.com EUDAMED record Report an error
Suzhou Powersite Electric FDA EU representative : MedPath GmbH (Germany) China IIb MDR EUDAMED record Report an error
Delta Electronics EU representative : Delta Electronics (Netherlands) B.V. (Netherlands) Taiwan IIb 93/42 EUDAMED record Report an error
Shimadzu FDA EU representative : Shimadzu Europa GmbH (Germany) Japan IIb 93/42 Website EUDAMED record Report an error
Beijing Wandong Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb 93/42 EUDAMED record Report an error
Ecotron FDA EU representative : Obelis s.a. (Belgium) South Korea IIb 93/42 EUDAMED record Report an error
Innomed FDA Hungary IIb 93/42 Website EUDAMED record Report an error
Drgem FDA EU representative : Obelis s.a. (Belgium) South Korea IIb MDR Website EUDAMED record Report an error
Jiangxi Hawk Medical Supplies EU representative : Umedwings Netherlands B.V. (Netherlands) China IIa 93/42 EUDAMED record Report an error
Liaoning DTKL Technology EU representative : Kingsmead Service B.V. (Netherlands) China IIb MDR EUDAMED record Report an error
Sedecal FDA Spain IIb MDR Website regulatory@sedecal.com EUDAMED record Report an error
Sontu FDA EU representative : MedNet EC-REP GmbH (Germany) China IIb 93/42 EUDAMED record Report an error
Spellman High Voltage Electronics FDA Germany IIb MDR info@spellmanhv.de EUDAMED record Report an error
Spellman High Voltage Electronics (Suzhou Industrial Park) EU representative : Spellman High Voltage Electronics GmbH (Germany) China IIb MDR information@spellmanhv.cn EUDAMED record Report an error
Stark İmplant Teknolojileri Sanayi Ve Diş Ticaret Şirketi Türkiye IIb 93/42 info@starkimplants.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) 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
Varex Imaging Corporation Present in Europe in other categories United States Varex Imaging registered
Carestream Health, Inc. Present in Europe in other categories United States QG-40-2 QG-40-SE QG-80 QG-50-2 QG-32-3 QG-50-SE registered
Communications & Power Industries Canada, Inc. Canada CMP 200 DR Indico IQ CMP 150 RAD MOBILE NANO MOBILE DR CMP200 DR registered
Iray Imaging Technology (Haining) Limited China iRay registered
DELTA ELECTRONICS, INC. CHUNGLI 5 PLANT – Delta registered
EMD Technologies Canada Epsilon High Voltage Generator Epsilon High Volatge Generator registered
Del Medical, Inc. United States Del Medical, Inc. registered
GE Medical Systems Present in Europe in other categories United States Senographe Pristina not applicable K954666 (1995)
CMR X-Ray, LLC United States – registered
Can Technomed Trading LTD. Canada – registered
Carestream Healthcare International Company Limited Present in Europe in other categories China – registered
DRTECH Corporation Present in Europe in other categories South Korea – registered
GE HealthCare Technologies Inc. Present in Europe in other categories United States – registered
Gilardoni S.P.A. Present in Europe in other categories Italy – registered
HEFEI MT MEDICAL CO.,LTD. Present in Europe in other categories China – registered
SG Healthcare Co., Ltd. Present in Europe in other categories South Korea – registered
SHINYOUNG FOR M CO.,LTD. Present in Europe in other categories South Korea – registered
Siemens Healthineers AG Present in Europe in other categories Germany – registered
Spellman GmbH Germany – registered
Summit Industries, Inc. Present in Europe in other categories United States – K850117 (1985)

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