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Sources: EU EUDAMED, US FDA
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Country: Germany
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Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·July 27, 2016
ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·May 16, 2018
Duschhandlauf glatt,rechts 764x764x1200mm
Device
EU MDR
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Eu Md Class 1
·Lehnen GmbH·On the market·6 countries
Dr. Franz Köhler Chemie GmbH
Manufacturer
🇩🇪 Germany
Fette Pharma GmbH
Manufacturer
🇩🇪 Germany
Murnauer Markenvertrieb GmbH
Manufacturer
🇩🇪 Germany
DermaTools Biotech GmbH
Manufacturer
🇩🇪 Germany
ImmuChrom GmbH
Manufacturer
🇩🇪 Germany
LSK-Wintrich GmbH
Manufacturer
🇩🇪 Germany
Dr. Wittmann GmbH & Co. KG
Manufacturer
🇩🇪 Germany·1 Basic UDI-DI·1 Device
VEPRO AG
Manufacturer
🇩🇪 Germany·1 Basic UDI-DI·1 Device·DQS Medizinprodukte GmbH
Acousticon Hörsysteme GmbH
Manufacturer
🇩🇪 Germany·7 Basic UDI-DIs·11 Devices
Nucleoss Europe GmbH
Manufacturer
🇩🇪 Germany·125 Basic UDI-DIs·143 Devices·Szutest Uygunluk Değerlendirme A.Ş. and Szutest Uygunluk Değerlendirme A.Ş.
Wareg Verpackungs GmbH
Manufacturer
🇩🇪 Germany
SWL Medizin GmbH
Manufacturer
🇩🇪 Germany·1 Basic UDI-DI·1 Device·Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi
OSARTIS GmbH
Manufacturer
🇩🇪 Germany
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
Manufacturer
🇩🇪 Germany
MEDEALIS GmbH
Manufacturer
🇩🇪 Germany
Omicron-Laserage Laserprodukte GmbH
Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·MDC MEDICAL DEVICE CERTIFICATION GMBH
Sirona Dental Systems GmbH
Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·3 Devices