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In vitro diagnostic medical devices
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IVD instruments
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Chemistry / immunochemistry instruments
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Blood gas analysis / electrolyte instruments
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Blood gas analysers
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Blood gas analysers - with additional parameters (PH, po2, pco2, hct + metabolites + electrolytes, co-oximeter parameters and coagulation parameters)
Blood gas analysers - with additional parameters (PH, po2, pco2, hct + metabolites + electrolytes, co-oximeter parameters and coagulation parameters)
W0201040102
60 devices
Devices
Blood Gas Electrolyte Analyzer
Shenzhen Cornley Bio-Medical Co., Ltd.
·
,
CN
Class A
CE/IVDR
Electrolyte analyzer
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
Electrolyte Analyzer
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
Electrolyte analyzer
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
Blood Gas Electrolyte Analyzer
Shenzhen Cornley Bio-Medical Co., Ltd.
·
,
CN
IVD General
CE/IVDR
CE/IVDD
Electrolyte Analyzer
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
Blood Gas Analyzer
Guangzhou Wondfo Biotech Co., Ltd.
·
,
CN
Class A
CE/IVDR
GEM Premier 7000 with iQM3
Open recall
Instrumentation Laboratory Company
·
,
US
Class A
FDA 510(k)
K223608
Active
Cleared 10 Aug 2023
CE/IVDR
+1
authorizations
Electrolyte Analyzer
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
GEM Premier 3500
Instrumentation Laboratory Company
·
,
US
Class A
CE/IVDR
GUDID
on market
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