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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
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
NADAL® Norovirus GI/GII Test
nal von minden GmbH
·
,
Germany
IVD General
CE/IVDD
Lyher
Hangzhou Laihe Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
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
SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Adenovirus Rapid Test
Zhejiang Greylynx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Astrovirus Antigen Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
Rubella.Virus(RV) IgM/IgG Test(Serum/Plasma)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Monkeypox Virus IgM Test Kit (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit
Jiangsu Bioperfectus Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
HSV Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
RV Rubella Antibodies IgM/IgG Rapid Test Kit(Colloidal Gold)
Qingdao Hightop Biotech Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
Influenza A/B+COVID-19/RSV Combo Ag Test
CorDx, Inc.
·
,
United States
IVD for self-testing
CE/IVDD
ONE STEP Malaria (P.F) Rapid Test (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
ONE STEP Anti-TP Rapid Test (Colloidal Gold)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Malaria antigen P.fPan Rapid Test Kit
Triplex International Biosciences (China) Co., LTD.
·
,
China
IVD General
CE/IVDD
Rota/Adeno Test
Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Lyher
Hangzhou Laihe Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
Rotavirus-Adenovirus Combo Rapid Test (Feces)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19(SARS-CoV-2) Antigen Test Kit
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
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