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In vitro diagnostic medical devices
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Infectious diseases
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Infectious immunology - rapid tests & point of care
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Other virology rt & poc
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Virology - rt & poc - other
Virology - rt & poc - other
W0105099099
641 devices
Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)
Jiangsu Medomics Medical Technology Co., Ltd.
·
,
China
Class C
CE/IVDR
EU-TDA-FI-06912-800035-2025-1
Active
Valid to Jan 2030
FluCov2
Dyonmed SA
·
,
Greece
IVD General
CE/IVDD
Rapid HEV IgG/IgM Combo Test Card
Xiamen Boson Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
HPIV Antigen Rapid Test (Fluorescence Immunochromatographic Assay)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
Shenzhen Huian Biosci Technology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
COV19 qcLAMP kit
Biopix Dna Technology P.C.
·
,
Greece
IVD General
CE/IVDD
biotical Astrovirus Positive control (30u)
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Tb MPT64
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 & Flu & RSV Antigen Combo Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)
Anhui Deepblue Medical Technology Co., Ltd
·
,
China
Class C
CE/IVDR
EU-TDA-FI-20642-800030-2025-1
Active
Valid to Mar 2030
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
Syphilis (Tp) Ab Rapid Test Cassette (Colloidal Gold)
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rotavirus-Adenovirus-Norovirus-Astrovirus Combo Rapid Test(Feces)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
EZER COVID-19 Antigen Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD for self-testing
CE/IVDD
COVID-19 Antigen Rapid Test Kit
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)- Saliva
Anhui Deepblue Medical Technology Co., Ltd
·
,
China
IVD for self-testing
CE/IVDD
Rapid Adenovirus Antigen Test Card
Xiamen Boson Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 And Influenza A/B Antigen Combo Test
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
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