3,435 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdd
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VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
Device
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·On the market
NanoRepro SARS-CoV-2 Antigen Rapid Test (Viromed)
Device
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·On the market
VIROLOGY - NA REAGENTS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Daan Gene Co., Ltd.·On the market
ALDOSTERONE
Device
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·On the market·32 countries
Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)
Device
EU IVDD
·
Eu Ivd General
·BioDetect(Xiamen)Biotechnology Co., Ltd.·On the market
VITAMIN B12
Device
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·On the market·32 countries
SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
NanoRepro SARS-CoV-2 Antigen Schnelltest (Viromed) (5er Kit) [SP/EN]
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·NanoRepro AG·1 device
Analysis Software for PCR-Fluorescence Detection Data
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
Aldosterone Chemiluminescent Immunoassay Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
Detection Kit for 2019-nCoV (PCR-Fluorescence)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Daan Gene Co., Ltd.·1 device
cobas IGRA SARS-CoV-2 Tubes
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Invitros Co., Ltd·1 device
KET-1
Device
EU IVDD
·
Eu Ivd Self Testing
·Apex Biotechnology Corp.·No longer on the market
Contrex Plus III
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Apex Biotechnology Corp.·On the market
GlucoSure Autocode
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Apex Biotechnology Corp.·On the market
UASure II
Device
EU IVDD
·
Eu Ivd Self Testing
·Apex Biotechnology Corp.·On the market·4 countries
HemoSmart GOLD
Device
EU IVDD
·
Eu Ivd Self Testing
·Apex Biotechnology Corp.·On the market·3 countries
HemoSmart GOLD
Device
EU IVDD
·
Eu Ivd Self Testing
·Apex Biotechnology Corp.·On the market·3 countries
THE EDGE
Device
EU IVDD
·
Eu Ivd Self Testing
·Apex Biotechnology Corp.·On the market·6 countries