16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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Brain-Boy
Device
EU MDD
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Eu Md Class 2a
·MediTECH Electronic GmbH·On the market·11 countries
Brain-Boy slow
Device
EU MDD
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Eu Md Class 2a
·MediTECH Electronic GmbH·On the market·12 countries
BILLY BOY MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Gründler GmbH
Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·SGS FIMKO OY
Fiagon GmbH
Manufacturer
🇩🇪 Germany·14 Basic UDI-DIs·33 Devices·SGS FIMKO OY
PAUSCH Medical GmbH
Manufacturer
🇩🇪 Germany·SGS FIMKO OY
Rhyk Technologies GmbH
Manufacturer
🇩🇪 Germany·SGS FIMKO OY
Brain-Boy Universal Standard
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·MediTECH Electronic GmbH·1 device
Brain-Boy Universal Slow Version
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·MediTECH Electronic GmbH·1 device
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
FI24/00000064
Certificate
MDR QMS·Fiagon GmbH·SGS FIMKO OY
FI23/00000052
Certificate
MDR QMS·PAUSCH Medical GmbH·SGS FIMKO OY
FI23/00000046
Certificate
MDR QMS·Rhyk Technologies GmbH·SGS FIMKO OY
FI23/00000013
Certificate
MDR QMS·Gründler GmbH·SGS FIMKO OY
MedPath GmbH
Authorized representative
🇩🇪 Germany·537 Manufacturers·13464 Devices