10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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opt-on 3.3
Device
EU MDR
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Eu Md Class 1
·orangedental GmbH & Co. KG·On the market·2 countries
opt-on 2.7
Device
EU MDR
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Eu Md Class 1
·orangedental GmbH & Co. KG·On the market·2 countries
opt-on
Basic UDI-DI
EU MDR
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Eu Md Class 1
·orangedental GmbH & Co. KG·2 devices
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.
FDA Enforcement
Class II
·Terminated·Brainlab AG·November 11, 2015
READY-MADE ORTHOTIC SHOES
Device
EU MDR
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Eu Md Class 1
·OPED GmbH·On the market·4 countries
EVENup
Basic UDI-DI
EU MDR
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Eu Md Class 1
·OPED GmbH·1 device
STEPPER EYEWEAR Marketing Office Germany UG
Authorized representative
🇩🇪 Germany·1 Manufacturer
Patient Guard Europe UG
Authorized representative
🇩🇪 Germany·13 Manufacturers·10 Devices
aktivmed GmbH
Importer
🇩🇪 Germany·4 Manufacturers
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices