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In vitro diagnostic medical devices
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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
biotical Norovirus Gen I + II Card (+PC)
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
COVID-19 IgG/IgM Antibody Rapid Test Kit
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
Accu-Tell® SARS-CoV-2 (Nasopharyngeal Swab)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Norovirus/Rotavirus/Adenovirus Combo Rapid Test Cassette
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD General
CE/IVDD
ReaScan+ PUUMALA IgM
Reagena Oy
·
,
Finland
Class B
CE/IVDD
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
Enterovirus Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rapid Flu A&B+RSV+Adeno Antigen Test
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
V76 092305 0014
Active
Valid to Apr 2030
Monkeypox Virus Nucleic Acid Detection Kit
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
biotical Rotavirus + Adenovirus Card (+PC +NC)
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
biotical Astrovirus Card (+PC)
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
Jiangsu Konsung Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rapid SARS-CoV-2 Antigen Test Card
BioDetect（Xiamen）Biotechnology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Adenovirus Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
Jiangsu Konsung Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Enterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing)
Shanghai BioGerm Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19 (SARS-CoV-2) Antigen Test Kit- Saliva
Anhui Deepblue Medical Technology Co., Ltd
·
,
China
IVD for self-testing
CE/IVDD
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
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