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Emdyca

Bioimaging and radiotherapy instrumentsNuclear medicine instrumentsVarious instruments for nuclear medicine

Automatic dose calibrators

EMDN code Z11029005

7 manufacturers, 9 models including 9 on the market, 6 countries

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Manufacturers registered in Europe (EUDAMED) 7
  • 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
Nuvia Germany I MDR EUDAMED record Report an error
Tema Sinergie Italy I, IIb MDR Website EUDAMED record Report an error
Capintec FDA EU representative : Atlantico Systems, Ltd. (Ireland) United States I MDR Website EUDAMED record Report an error
Comecer FDA Netherlands I MDR Website infonl@comecer.com EUDAMED record Report an error
Lemer Pax FDA France I MDR Website contact@lemerpax.com EUDAMED record Report an error
Lynax Czechia I MDR Website EUDAMED record Report an error
Murphil Italy I MDR 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) 3

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
Theragenics Corp. United States I-Seed Agx100 TheraSeed registered
STANDARD IMAGING INC. Present in Europe in other categories United States Standard Imaging HDR 1000 Plus Standard Imaging IVB 1000 Well Chamber K013548 (2001)
Mirion Technologies, Inc. United States – registered

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