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In vitro diagnostic medical devices
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IVD instruments
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Sample processing systems
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Various sample processing instruments
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Various sample processing instruments - other
Various sample processing instruments - other
W02069099
403 devices
Nucleic Acid Extraction System
Sansure Biotech Inc.
·
,
China
Class A
CE/IVDR
Mini Purifier
Suzhou Acumen Biomedical Technology Co., LTD.
·
,
China
Class A
CE/IVDR
SLR for cobas 8100
Hitachi High-Tech Corporation
·
,
Japan
Class A
CE/IVDR
Automated Liquid Handling System
Xi'an Tianlong Science and Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Sample Processing System
Changsha Imadek Intelligent Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Automatic Digital Slice Scanning System
Suzhou Betrue Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Automated Liquid Handling Workstation
Nanjing Vazyme Medical Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Automatic Digital Slice Scanning System
Suzhou Betrue Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Automatic nucleic acid extractor
Changsha Imadek Intelligent Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Automated Nucleic Acid Extraction Instrument (EX3600)
Shanghai Zj Bio-Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
Sample tip (including conductive)
Suzhou Acumen Biomedical Technology Co., LTD.
·
,
China
Class A
CE/IVDR
Nucleic Acid Extraction System
Jiangsu Bioperfectus Technologies Co., Ltd.
·
,
China
Class A
CE/IVDR
GUDID
on market
ZiXpress 96 Dx
Zinexts Life Science Corp.
·
,
Taiwan
Class A
CE/IVDR
Automatic nucleic acid extractor
Changsha Imadek Intelligent Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Sample tip (including conductive)
Suzhou Acumen Biomedical Technology Co., LTD.
·
,
China
Class A
CE/IVDR
Sample tip (including conductive)
Suzhou Acumen Biomedical Technology Co., LTD.
·
,
China
Class A
CE/IVDR
BreathID® Hp Lab system
Meridian Bioscience Israel Ltd.
·
,
Israel
IVD General
FDA 510(k)
K221896
Active
Cleared 19 Dec 2022
CE/IVDD
+1
authorizations
Fontus Automated Liquid Handling Workstation
Revvity Health Sciences, Inc - MA
·
,
United States
Class A
CE/IVDR
GUDID
on market
Sample tip (including conductive)
Suzhou Acumen Biomedical Technology Co., LTD.
·
,
China
Class A
CE/IVDR
SCM for cobas 8100
Hitachi High-Tech Corporation
·
,
Japan
Class A
CE/IVDR
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