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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
Automatic Digital Slice Scanning System
Suzhou Betrue Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
KingFisher™ Apex Dx 96 Combi Head
Life Technologies Holdings Pte Ltd.
·
,
Singapore
Class A
CE/IVDR
GUDID
on market
Nucleic Acid Extraction System
Sansure Biotech Inc.
·
,
China
Class A
CE/IVDR
TLJ3000 for cobas 8100
Hitachi High-Tech Corporation
·
,
Japan
Class A
CE/IVDR
DSP for cobas 8100
Hitachi High-Tech Corporation
·
,
Japan
Class A
CE/IVDR
Macro & Micro-Test Automatic Nucleic Acid Extractor
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
Automatic Digital Slice Scanning System
Suzhou Betrue Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Kfbio
Ningbo Konfoong Bioinformation Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
IPB for cobas 8100
Hitachi High-Tech Corporation
·
,
Japan
Class A
CE/IVDR
Sample tip (including conductive)
Suzhou Acumen Biomedical Technology Co., LTD.
·
,
China
Class A
CE/IVDR
Automated Nucleic Acid Extraction Workstation
Jiangsu Bioperfectus Technologies Co., Ltd.
·
,
China
Class A
CE/IVDR
Incubator
Changsha Yingtai Instrument Co., Ltd
·
,
China
Class A
CE/IVDR
GUDID
on market
Automatic Digital Slice Scanning System
Suzhou Betrue Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Incubator
Changsha Yingtai Instrument Co., Ltd
·
,
China
Class A
CE/IVDR
GUDID
on market
JANUS G3 Automated Workstation
Revvity Health Sciences, Inc - MA
·
,
United States
Class A
CE/IVDR
GUDID
on market
Nanomation™ G1 Pro
Nanomics Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
BreathID® Smart
Meridian Bioscience Israel Ltd.
·
,
Israel
IVD General
FDA 510(k)
K223185
Active
Cleared 10 Nov 2022
CE/IVDD
+1
authorizations
Sample tip (including conductive)
Suzhou Acumen Biomedical Technology Co., LTD.
·
,
China
Class A
CE/IVDR
RFU for cobas 8100
Hitachi High-Tech Corporation
·
,
Japan
Class A
CE/IVDR
Automatic Digital Slice Scanning System
Suzhou Betrue Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
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