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Emdyca

Bioimaging and radiotherapy instrumentsVarious bioimaging and radiotherapy instruments

Various bioimaging and radiotherapy instruments - hardware accessories

EMDN code Z119080

9 manufacturers, 126 models including 121 on the market, 6 countries

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Manufacturers registered in Europe (EUDAMED) 9
  • 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
Phantomlab FDA EU representative : Hoff & Lowendahl AB (Sweden) United States
95 others
I MDR, 93/42 Website info@phantomlab.com EUDAMED record Report an error
Fluoptics FDA France
7 others
I, IIa MDR EUDAMED record Report an error
Optomed FDA Finland I MDR Website regulatory@optomed.com EUDAMED record Report an error
Moor FDA EU representative : Advena Limited (Malta) and 1 other United Kingdom (ex Northern Ireland) I MDR Website EUDAMED record Report an error
Baxter FDA Germany I MDR Website EUDAMED record Report an error
MediCapture FDA EU representative : MEDICAPTURE EUROPE B.V. (Netherlands) United States I MDR Website info@medicapture.com EUDAMED record Report an error
Michelson Diagnostics FDA EU representative : Medical Device Management Ltd (Ireland) United Kingdom (ex Northern Ireland) IIa MDR Website admin@vivosight.com EUDAMED record Report an error
Shanghai Leading Technology EU representative : R Sight B.V. (Netherlands) China I MDR EUDAMED record Report an error
Varian Medical Systems FDA EU representative : Siemens Healthineers Nederland B.V. (Netherlands) United States 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) 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
Providus Holdings, Inc. – Catphan® ECTphan™ Magphan® Corgi® Low Contrast MITA Head Phantom Low Contrast MITA Body Phantom registered
Cortechs Labs, Inc. United States – registered
GE HealthCare Technologies Inc. Present in Europe in other categories United States – registered
LEEDS TEST OBJECTS LTD United Kingdom – registered
Philips Medical Systems Nederland B.V. Present in Europe in other categories Netherlands – registered
Pro-Project Poland – registered
Qualiformed Sarl Present in Europe in other categories France – registered
Radiation Products Design, Inc. United States – registered
Resoundant, Inc. Present in Europe in other categories United States – registered
Sun Nuclear Corp. Present in Europe in other categories United States – registered

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