Skip to content
Emdyca

Bioimaging and radiotherapy instrumentsDigital bioimaging management instrumentsVarious digital bioimaging management instruments

Diagnostic imaging workstations

EMDN code Z11069005

12 manufacturers, 28 models including 24 on the market, 10 countries

Export to CSV
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
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) Japan
1 other
 IIa, IIb MDR, 93/42 EUDAMED record Report an error
Threepalmsoft FDA EU representative : Wellkang Ltd (Northern Ireland) United States I MDR Website info@threepalmsoft.com EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States I, IIa MDR EUDAMED record Report an error
Tatramed Slovakia I, IIa MDR, 93/42 Website info@tatramed.sk EUDAMED record Report an error
Dental Wings FDA Germany IIa MDR regulatory@dental-wings.com EUDAMED record Report an error
Epsilonhealthcare EU representative : mdi Europa GmbH (Germany) India IIb MDR Website EUDAMED record Report an error
Ims Giotto FDA Italy I MDR Website EUDAMED record Report an error
L.M. Medical Division Italy I MDR Website info@lmmedicaldivision.com EUDAMED record Report an error
Shenzhen Sunmc Dental Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Tur-Med Hastane Malz San Tic Şti Türkiye I MDR Website info@turmedonline.com EUDAMED record Report an error
Ultraviol Poland I MDR Website EUDAMED record Report an error
Intrasense No model still on the market France IIa MDR, 93/42 Website contact@intrasense.fr 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
BIOMET SPINE LLC – TIMBERLINE MPF LATERAL MODULAR PLATE FIXATION SYSTEM Timberline® MPF Lateral Interbody Modular Plate Fixation System registered
Faxitron Bioptics, LLC United States Faxitron Faxitron Path Faxitron OR Faxitron Core K183142 (2019)
Kubtec Present in Europe in other categories – KUBTEC XPERT80 XPERT80L XPERT42 XPERT40 XPERT84 registered
CIRDAN IMAGING LIMITED Present in Europe in other categories United Kingdom Solas OR CoreLite K213691 (2021)
CompAI Healthcare (Suzhou) Co.,ltd China TrueView K230140 (2023)
CompAI MedTech (Suzhou) Co., Ltd. China TrueView registered
Clarix Imaging Corporation United States Clarix Imaging Corps K192939 (2019)
CompAI Healthcare (Shenzhen) Co.,ltd China TrueView K202713 (2020)
Kub Technologies, Inc. Present in Europe in other categories United States – K210955 (2021)
XEOS Medical Present in Europe in other categories Belgium – registered

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.

Related categories