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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
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
VIRAPID® ADENOVIRUS Ag FIA
Vircell, S.L
·
,
Spain
Class B
CE/IVDR
SARS-CoV-2 Neutralizing Antibody Detection Kit (Fluorescence Immunoassay)
Shenzhen Zijian Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
COVID-19 Antigen Nasal Test Kit
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Rota / Adeno kasetki 20 szt.
BioMaxima Spółka Akcyjna
·
,
Poland
Class B
CE/IVDR
Human metapneumovirus Antigen Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
Rapid COVID-19 (Antigen) Self-Test
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Rota/Adeno Ag Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Accu-Tell® Human Monkeypox virus Cassette (Lesion exudate swab)
AccuBioTech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Simple RSV-RespirAdeno
Operon, S.A.
·
,
Spain
Class B
CE/IVDR
RSV/Influenza A+B Combo Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 AntigenTest kit (LFIA)
Jiangsu Medomics Medical Technology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Mycoplasma pneumoniae Antigen Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit
Shanghai BioGerm Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Norovirus/Rotavirus/Adenovirus Combo Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 Antigen Rapid Qualitative Test
Qingdao Huaren Medical Product Co., Ltd.
·
,
China
IVD General
CE/IVDD
Mycoplasma pneumoniae Ag Rapid
Zhejiang Greylynx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
biotical Rotavirus + Adenovirus Card (+PC)
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
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
Mycoplasma pneumoniae IgM Antibody Rapid Test Kit
Shanghai BioGerm Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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