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Emdyca

Bioimaging and radiotherapy instrumentsVarious bioimaging and radiotherapy instruments

Laser systems for patient positioning

EMDN code Z119010

4 manufacturers, 10 models including 6 on the market, 4 countries

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Manufacturers registered in Europe (EUDAMED) 4
  • 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
C-RAD Positioning FDA Sweden
1 other
 I, IIb MDR, 93/42 Website info@c-rad.com EUDAMED record Report an error
Radon Tibbi̇ Malzemeler İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Türkiye I 93/42 Website info@radonfix.net EUDAMED record Report an error
Klarity Medical & Equipment（GZ） EU representative : Lotus NL B.V. (Netherlands) China I MDR sales@klarity-medical.com EUDAMED record Report an error
Lap Laser Applikationen FDA Germany I MDR Website info@lap-laser.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) 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
Guangdong Meicen Medical Equipment Co., Ltd. Present in Europe in other categories China Meicen registered
AADCO MEDICAL, INC. United States Hercules AADCO MRI-Safe Rayshield registered
Sun Nuclear Corp. Present in Europe in other categories United States CT Sim+ Sun Nuclear MICRO+ MR Sun Nuclear MICRO Sun Nuclear MICRO+ registered
Aktina Corp. Present in Europe in other categories – Cross-Hair Reticule, Open-Air Cross-Hair Reticule, Radiation Opaque Port Film Graticule, Siemens Compatible Cross-Hair Reticule, XRETIC Port Film Graticule, Tray Mount, Elekta Compatible Port Film Graticule, Latch Mount, Elekta Compatible registered
HUESTIS MACHINE CORPORATION United States Huestis Centralite Patient Positioning Laser registered
Amcad Biomed Corporation Present in Europe in other categories Taiwan Head & Neck Laser Alignment Tool registered
Aktina Medical Corporation Present in Europe in other categories United States – registered
GE HealthCare Technologies Inc. Present in Europe in other categories United States – registered
Infitek Co., Ltd. Present in Europe in other categories China – registered
Innokas Yhtyma Oy Present in Europe in other categories Finland – registered
LAP of America Laser Applications LLC United States – registered
Labpeak Co.,Ltd China – registered
Philips Medical Systems Nederland B.V. Present in Europe in other categories Netherlands – registered
Scitek Global Co.,Ltd China – registered
Shenzhen Tengfei Yu Technology Co., Ltd. Present in Europe in other categories China – registered

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