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Emdyca

Bioimaging and radiotherapy instrumentsRadiotherapy and radiosurgery instrumentsLinear accelerators

Linear accelerators - consumables

EMDN code Z11010185

2 manufacturers, 7 models including 7 on the market, 2 countries

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Manufacturers registered in Europe (EUDAMED) 2
  • 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
Zeiss FDA Germany
1 other
 IIa, III MDR, 93/42 Website EUDAMED record Report an error
Aktina FDA EU representative : European Healthcare & Device Solutions Ltd. (Ireland) United States IIa MDR 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) 15

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
ACTION PRODUCTS, INC. Present in Europe in other categories United States Action® K811528 (1981)
Icad, Inc. United States Balloon Applicator HDR X-ray Source 2.2 Balloon Applicator Kit (10) Applicator End Cap, 35 mm Vaginal Applicator Set with Base and Clamp Surface Applicator Cone, 10 mm K153570 (2016)
Nucletron Corp. Present in Europe in other categories United States Esteya K213942 (2022)
XSTRAHL LIMITED Present in Europe in other categories United Kingdom Xstrahl Photoelectric Therapy System Xstrahl 300 X-Ray System - Floor Xstrahl 200 X-Ray System - Ceiling Xstrahl 150 X-Ray System Floor Xstrahl 100 X-Ray System Xstrahl 300 X-Ray System Ceiling K230611 (2023)
Sensus Healthcare, Inc. Present in Europe in other categories United States Sensus K182641 (2019)
CDR Systems Inc Present in Europe in other categories Canada Bolus - Gel (w/o Film) Bolus - Gel (film) registered
Elekta , Ltd. Present in Europe in other categories United Kingdom – registered
Empyrean Medical Systems, Inc. United States – registered
Fabtech Precision Sheet Metal, LLC United States – registered
HUESTIS MACHINE CORPORATION United States – K904005 (1990)
Koplak Corp United States – registered
Parker Industrial S de RL de CV Mexico – registered
RBM SERVICES, LLC. United States – registered
Stellartech Research Corp. United States – registered
Voxel Ray Solutions, LLC United States – K250692 (2025)

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