233 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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KBL GmbH
FDA registration
KBL GmbH·2 products·🇩🇪 Germany
medilogic IBG - IkonoBaroGraph
Device
EU MDR
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Eu Md Class 1
·T&T medilogic Medizintechnik GmbH·On the market
DG 25x65 N.1,5H 1 Eck abg Papzw 20x50 Papp Superior CE
Device
EU IVDR
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Eu Ivd Class A
·Paul Marienfeld GmbH & Co. KG·On the market·32 countries
medilogic IBG - IkonoBaroGraph
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·T&T medilogic Medizintechnik GmbH·1 device
RACK F, 300µL CRYO.S BIOBANKING TUBE,BBG
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Greiner Bio-One GmbH·1 device
RACK F. 600µL CRYO.S BIOBANKING TUBE,BBG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Greiner Bio-One GmbH·1 device
Microgenics B.V. & Co. K.G.
Importer
🇩🇪 Germany
Pediatric care bed; Product Designation: KayserBett IDA;
FDA Enforcement
Class I
·Ongoing·KAYSERBETTEN GMBH & CO. KG·June 10, 2026
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
FDA Enforcement
Class II
·Terminated·Spiegelberg Gmbh & Co. KG·October 5, 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
Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·April 24, 2019
Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 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·February 6, 2019
Abbott Alinity i Processing Module LN 03R65-01 - 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·April 24, 2019
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
Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. Each system can be customized by combining one or more sample processing modules, in multiple configurations, with a system control module to form a single workstation. 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·September 4, 2019
Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology.
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·June 12, 2019
Alinity ci Level Sensor, Bulk Solution
FDA Enforcement
Class II
·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019
ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
FDA Enforcement
Class II
·Ongoing·Abbott Gmbh & Co. KG·June 3, 2020
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·December 4, 2019
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
FDA Enforcement
Class II
·Terminated·Abbott GmBH & Co. KG·December 4, 2019