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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
Adenovirus Rapid Test (Feces)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rotavirus & Adenovirus Antigen Rapid Test Cassette (Colloidal Gold)
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Adenovirus Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class B
CE/IVDR
SARS-CoV-2 Antigen Test
Xiamen Wiz Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
ReaScan TBE IgM
Reagena Oy
·
,
Finland
Class B
CE/IVDD
CE/IVDR
SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method)
Shenzhen Zijian Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
HPVix
Abcerion Diagnostics GmbH
·
,
Germany
IVD General
CE/IVDD
SARS-CoV-2/Flu A+B/AdV/RSV Antigen Rapid Test
Qingdao Hightop Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab)
Zhejiang Orient Gene Biotech 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
Rotavirus Rapid Test
Shenzhen Kang Sheng Bao Bio-Technology 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
Singclean
Hangzhou Singclean Medical Products Co., Ltd.
·
,
China
IVD General
CE/IVDD
KaiBiLi COVID-19 Antigen Pro
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
Rotavirus Test
Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
KaiBiLi COVID-19 Antigen Neo
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
Hantavirus Rapid Test (WB +2 more)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19 IgG/IgM Ab Rapid Test Kit
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
ReaScan DOBRAVA-HANTAAN IgM
Reagena Oy
·
,
Finland
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
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