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Emdyca

Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsDirect digital radiology (dr) systems

Multifunctional systems for direct digital radiology

EMDN code Z11031101

51 manufacturers, 154 models including 153 on the market, 15 countries

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Manufacturers registered in Europe (EUDAMED) 51
  • 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
Ge Hualun Medical Systems FDA EU representative : GE Medical Systems SCS (France) China
6 others
 IIb MDR, 93/42 eudamed@gehealthcare.com EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) Japan
5 others
 IIa MDR, 93/42 EUDAMED record Report an error
CMT Medical Technologies FDA EU representative : Obelis s.a. (Belgium) Israel
4 others
 IIa, IIb 93/42 EUDAMED record Report an error
Sirona Dental Systems FDA Germany
4 others
 IIb MDR, 93/42 Website contact@dentsplysirona.com EUDAMED record Report an error
Agfa FDA Belgium
3 others
 IIb MDR Website EUDAMED record Report an error
Dinamik Rontgen Sanayi Ve Ticaret Sirketi Türkiye
3 others
 IIb MDR info@d-xray.com EUDAMED record Report an error
Beijing Wandong Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
2 others
 IIb MDR, 93/42 EUDAMED record Report an error
Browiner FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
2 others
 IIb MDR Website EUDAMED record Report an error
Drgem FDA EU representative : Obelis s.a. (Belgium) South Korea IIb MDR Website EUDAMED record Report an error
Thales Avs France FDA France IIa, IIb MDR EUDAMED record Report an error
Kuanteng (Liaoning) Medical Devices EU representative : Lotus NL B.V. (Netherlands) China IIb MDR, 93/42 EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb MDR Website EUDAMED record Report an error
Visaris FDA EU representative : VISARIS d.o.o. (Slovenia) Serbia IIb 93/42 Website info@visaris.com EUDAMED record Report an error
Canon FDA EU representative : Canon Medical Components Europe B.V. (Netherlands) and 1 other Japan I, IIa, IIb MDR eudamed-info@mail.canon EUDAMED record Report an error
Drtech FDA EU representative : DRTECH Europe GmbH (Germany) South Korea IIa, IIb MDR Website EUDAMED record Report an error
General Medical Italia Swiss Branch EU representative : ITALIAN RADIOLOGY INDUSTRY SRL (Italy) Switzerland IIb MDR Website info@gmint.ch EUDAMED record Report an error
Philips FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands) China IIb MDR eudamed@philips.com EUDAMED record Report an error
Samsung FDA EU representative : Samsung Electronics GmbH (Germany) South Korea IIb MDR Website EUDAMED record Report an error
Siemens Healthcare FDA Germany IIb MDR, 93/42 Website contact@siemens-healthineers.com EUDAMED record Report an error
Zhuhai Perlead Medical Equipment EU representative : BioDomi GmbH (Germany) China IIb 93/42 EUDAMED record Report an error
A.T.S. Applicazione Tecnologie Speciali FDA Italy IIb 93/42 Website quality@atsmed.it EUDAMED record Report an error
BRS-Brieden Radiologische Systemlösungen Germany IIb MDR Website info@brs-radiologie.de EUDAMED record Report an error
Careray FDA EU representative : Lotus NL B.V. (Netherlands) China IIa MDR support@careray.com EUDAMED record Report an error
Dk FDA EU representative : Obelis s.a. (Belgium) South Korea IIb 93/42 Website EUDAMED record Report an error
Neusoftmedical FDA EU representative : Emergo Europe B.V. (Netherlands) China IIb MDR, 93/42 EUDAMED record Report an error
Prognosysmedical FDA EU representative : Obelis s.a. (Belgium) India IIb MDR Website info@prognosysmedical.com EUDAMED record Report an error
Runyes FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIa MDR EUDAMED record Report an error
SG Healthcare FDA EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea IIb 93/42 Website info@sghealthcare.com EUDAMED record Report an error
Shenzhen Angell Technology EU representative : Angell Technology GmbH (Germany) China IIb 93/42 EUDAMED record Report an error
Siemens Shanghai Medical Equipment EU representative : Siemens Healthineers AG (Germany) China IIb MDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Xera FDA Türkiye IIb 93/42 Website info@xera.com.tr EUDAMED record Report an error
Adaptix FDA EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) IIb MDR Website info@adaptix.com EUDAMED record Report an error
Allengers FDA EU representative : Easy Medical Device CommV (Belgium) India IIb MDR Website EUDAMED record Report an error
Control-X Medical Zrt Hungary IIb MDR EUDAMED record Report an error
Duerrdental FDA Germany IIb MDR Website regulatory@duerrdental.com EUDAMED record Report an error
E-COM Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb 93/42 EUDAMED record Report an error
General Medical Merate FDA Italy IIb MDR Website info@gmmspa.com EUDAMED record Report an error
Gms Med Italy IIb MDR Website info@medicalgms.com EUDAMED record Report an error
Jpi FDA EU representative : Emergo Europe B.V. (Netherlands) South Korea IIb MDR Website EUDAMED record Report an error
Konica Minolta FDA EU representative : Konica Minolta Business Solutions Europe GmbH (Netherlands) Japan IIb 93/42 EUDAMED record Report an error
Kubtec FDA EU representative : Advena Limited (Malta) United States I MDR Website EUDAMED record Report an error
Lanmage EU representative : Lotus NL B.V. (Netherlands) China IIb MDR EUDAMED record Report an error
Mdts Germany IIb MDR Website sales@mdts.swiss EUDAMED record Report an error
Mitosmedikal Türkiye IIa MDR Website EUDAMED record Report an error
Ningbo Youjoy Dental Equipment EU representative : SUNGO Europe B.V. (Netherlands) China IIa MDR ra01@runyes.com EUDAMED record Report an error
PROTEC X-ray Systems Germany IIb MDR info@protec-med.com EUDAMED record Report an error
Shantou Institute of Ultrasonic Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb MDR Website EUDAMED record Report an error
Skanray FDA EU representative : SKANRAY EUROPE SRL (Italy) India IIb 93/42 office@skanray.com EUDAMED record Report an error
Sontu FDA EU representative : MedNet EC-REP GmbH (Germany) China IIb 93/42 EUDAMED record Report an error
Villa Sistemi Medicali FDA Italy IIb MDR info@villasm.com EUDAMED record Report an error
Yian Medical Technology (Haining) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb MDR Website service@yian-medical.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) 10

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
Nano-X Imaging , Ltd. Israel TAP2D Nanox.ARC X Nanox.ARC K252649 (2026)
Block Imaging SAS United States – registered
Can Technomed Trading LTD. Canada – registered
EverX / Bindra Australia – registered
Fair Medical Co.,Ltd Japan – registered
GE HealthCare Technologies Inc. Present in Europe in other categories United States – registered
Kuehne GmbH Germany – registered
Pausch Corp. United States – K973864 (1998)
Pausch Medical GmbH Germany – K221949 (2023)
Zot Engineering Limited United Kingdom – registered

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