10 results
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17ms
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Sources: EU EUDAMED, US FDA
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Country: Netherlands
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HAS-BLED Score
Device
EU MDR
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Eu Md Class 2a
·Evidencio·On the market·2 countries
HAS-BLED Score for Major Bleeding Risk Calculator
Basic UDI-DI
EU MDR
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Eu Md Class 2a
·Evidencio·1 device
Royal Medix B.V.
Importer
🇳🇱 Netherlands·2 Manufacturers
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.
FDA Enforcement
Class III
·Terminated·ELITech Group B.V.·October 9, 2019
ACM Products B.V.
Importer
🇳🇱 Netherlands·3 Manufacturers
Toby's B.V.
Importer
🇳🇱 Netherlands·5 Manufacturers
Koopman International
Importer
🇳🇱 Netherlands·5 Manufacturers
Van der Logt Group B.V.
Importer
🇳🇱 Netherlands·7 Manufacturers
Dayes Europe B.V.
Importer
🇳🇱 Netherlands·8 Manufacturers
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices