Bioimaging and radiotherapy instrumentsDigital bioimaging management instruments
Digital computed radiography (cr) systems
EMDN code Z110602
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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Digiray FDA EU representative : Obelis s.a. (Belgium) | South Korea |
28 others
|
IIa MDR | Website EUDAMED record Report an error |
| Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) | Japan | IIa MDR | EUDAMED record Report an error | |
| Agfa FDA | Belgium | IIa 93/42 | Website EUDAMED record Report an error | |
| Carestream Dental FDA EU representative : TROPHY (France) | United States | IIa MDR | EUDAMED record Report an error | |
| Konica Minolta FDA EU representative : Konica Minolta Business Solutions Europe GmbH (Netherlands) | Japan |
|
IIa 93/42 | EUDAMED record Report an error |
| Fussen Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
IIa MDR | EUDAMED record Report an error |
| Ningbo Youjoy Dental Equipment EU representative : SUNGO Europe B.V. (Netherlands) | China |
|
I MDR | ra01@runyes.com EUDAMED record Report an error |
| Ray FDA EU representative : Emergo Europe B.V. (Netherlands) | South Korea | I MDR | Website EUDAMED record Report an error | |
| Runyes FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | I MDR | EUDAMED record Report an error | |
| Shanghai Handy Medical Equipment FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | I MDR | EUDAMED record Report an error | |
| Veirun FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | I MDR | info@veirun.com EUDAMED record Report an error | |
| Xpectvision FDA EU representative : Wellkang Ltd (Northern Ireland) | China | IIa 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) 6
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.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Carestream Health, Inc. Present in Europe in other categories | United States | LANEX Regular Screens Select Cassette with LANEX Medium Screens Select Cassette with LANEX Regular Screens Imaging Plate LANEX Fine Screens X-OMATIC Regular Screens | registered |
| Flow X Ray Corporation | United States | Wolf X-Ray | registered |
| 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | – | Visionary by 3D Dental | registered |
| DARBY DENTAL SUPPLY, LLC | – | Darby Dental Supply, LLC | registered |
| Dimedi Co., Ltd. Present in Europe in other categories | South Korea | – | registered |
| Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd | India | – | registered |
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