12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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EBA AG
Manufacturer
🇩🇪 Germany
DxA 5000, DxA 5000 Fit
Device
EU IVDR
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Eu Ivd Class A
·Beckman Coulter Biomedical GmbH·On the market·32 countries
Touch Mono Part darkchocolate mix
Device
EU MDR
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Eu Md Class 1
·ellen wille THE HAIR-COMPANY GmbH·On the market·31 countries
VITAPAN PLUS®
Device
EU MDD
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Eu Md Class 2a
·VITA Zahnfabrik·No longer on the market·1 country
DxA Automation System
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Beckman Coulter Biomedical GmbH·5 devices
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical GmbH·July 26, 2023
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical GmbH·July 26, 2023
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Biomedical GmbH·September 30, 2020
medic-o-planet GmbH
Importer
🇩🇪 Germany
MedDevConsult GmbH
Authorized representative
🇩🇪 Germany·8 Manufacturers·14 Devices
EBA AG
System producer
🇩🇪 Germany
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices