19 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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MEDI CAL HealthCare GmbH
Manufacturer
🇩🇪 Germany·3 Basic UDI-DIs·3 Devices
BIACLASSICTABS
Device
EU MDD
·
Eu Md Class 1
·MEDI CAL HealthCare GmbH·On the market
BIAPHASERTABS
Device
EU MDD
·
Eu Md Class 1
·MEDI CAL HealthCare GmbH·On the market
BIACORPUS RX 4004M
Device
EU MDD
·
Eu Md Class 1
·MEDI CAL HealthCare GmbH·On the market
BLOTrix System 4.2/ BLOTrix Reader C1 L
Device
EU IVDR
·
Eu Ivd Class A
·BioSciTec GmbH·On the market
BLOTrix System 4.1/ BLOTrix Reader C1 L
Device
EU IVDR
·
Eu Ivd Class A
·BioSciTec GmbH·On the market
BLOTrix System 4.0/ BLOTrix Reader C1 L
Device
EU IVDR
·
Eu Ivd Class A
·BioSciTec GmbH·On the market
BIACLASSICTABS
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·MEDI CAL HealthCare GmbH·1 device
BIAPHASERTABS
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·MEDI CAL HealthCare GmbH·1 device
BIACORPUS RX 4004M
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·MEDI CAL HealthCare GmbH·1 device
CAL
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·TECO Medical Instruments, Production + Trading GmbH·1 device
CAL
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·TECO Medical Instruments, Production + Trading GmbH·1 device
B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC
FDA 510(k)
FDA Class 2
·Immunology
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
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·December 6, 2017
SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·December 6, 2017
N Latex CDT Kit
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·September 5, 2018
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·April 29, 2020
AJW Technology Consulting GmbH
Authorized representative
🇩🇪 Germany·18 Manufacturers·23 Devices