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Sources: EU EUDAMED, US FDA
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Country: Germany
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Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·June 5, 2019
KTR Europe GmbH
Authorized representative
🇩🇪 Germany·135 Manufacturers·3461 Devices
CJ Jeon / KTR Europe GmbH
Authorized representative
🇩🇪 Germany
ChulJoo Jeon / KTR Europe GmbH
Authorized representative
🇩🇪 Germany
ARTICARES PTE LTD
Importer
🇩🇪 Germany·1 Manufacturer
Roceso Medical GmbH
Importer
🇩🇪 Germany·1 Manufacturer
Venner Medical (Deutschland) GmbH
Importer
🇩🇪 Germany·1 Manufacturer
Leica Microsystems CMS GmbH
Importer
🇩🇪 Germany·3 Manufacturers
Promedics Medizinische Systeme GmbH
Importer
🇩🇪 Germany·12 Manufacturers
Bisping Medizintechnik GmbH
Importer
🇩🇪 Germany·13 Manufacturers
ASID BONZ GmbH
Importer
🇩🇪 Germany·12 Manufacturers
PAUL HARTMANN AG
Importer
🇩🇪 Germany·15 Manufacturers
Lohmann & Rauscher International GmbH & Co. KG
Importer
🇩🇪 Germany·23 Manufacturers
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices