11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Germany
×
Max Hauser Süddeutsche Chirurgiemechanik GmbH
Manufacturer
🇩🇪 Germany
DxA 5000, DxA 5000 Fit
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Biomedical GmbH·On the market·32 countries
MAX HAUSER SUDDEUTSCHE CHIRURGIEMECHANIK GMBH
FDA registration
MAX HAUSER SUDDEUTSCHE CHIRURGIEMECHANIK GMBH·36 products·🇩🇪 Germany
DxA Automation System
Basic UDI-DI
EU IVDR
·
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
(P)innauMed UG (haftungsbeschränkt)
Importer
🇩🇪 Germany·1 Manufacturer
MedAlliance Germany GmbH
Authorized representative
🇩🇪 Germany·2 Manufacturers
MED-RAS GmbH Regulatory Affairs Service
Authorized representative
🇩🇪 Germany·18 Manufacturers·235 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices