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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
Typhoid Antigen Rapid Test
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Capilia Adeno Neo Test Plate 10T/Box
TAUNS Laboratories, Inc.
·
,
Japan
IVD General
CE/IVDD
Multiple Rapid Real-Time PCR kit for Detection of A E gene and Omicron mutation…
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
ADV Antigen Rapid Test Device
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
COVID-19 Antigen Detection Kit-Nasal swab
New Gene (Hangzhou) Bioengineering Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
HSV 1/2 IgG/IgM Combo Rapid Test
Zhejiang Greylynx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Simple RespirAdeno
Operon, S.A.
·
,
Spain
Class B
CE/IVDR
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
VivaDiag™ Monkeypox Virus Ag Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rapid Adeno/Rota Virus Antigen Combo Test Card
Xiamen Boson Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
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
biotical Norovirus Gen I + II Card
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
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
KaiBiLi COVID-19 Antigen Saliva Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
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
Herpes simplex virus Rapid Test (Whole Blood +2 more)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
biotical Rotavirus + Adenovirus Card
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
COVID-19 Neutralization Antibody ELISA Test
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
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