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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
Electrolyte analyzer
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
Blood Gas and Chemistry Analyzer
Edan Instruments, Inc.
·
,
CN
IVD General
CE/IVDD
Blood Gas & Electrolyte Analyzer
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
Blood Gas & Electrolyte Analyzer
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
Blood Gas Electrolyte Analyzer
Shenzhen Cornley Bio-Medical Co., Ltd.
·
,
CN
Class A
CE/IVDR
Electrolytes Analyzer
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
GEM Premier 3500 (Refurbished)
Instrumentation Laboratory Company
·
,
US
Class A
CE/IVDR
GUDID
on market
Blood Gas Analyzer
Eaglenos Sciences, Inc.
·
,
CN
Class A
CE/IVDR
Blood Gas & Electrolyte Analyzer
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
GEM Premier 5000
Open recall
Instrumentation Laboratory Company
·
,
US
Class A
FDA 510(k)
K203790
Active
Cleared 20 Aug 2021
FDA 510(k)
K173403
Active
Cleared 29 Dec 2017
+2
authorizations
cornley
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
GEM Premier ChemSTAT
Instrumentation Laboratory Company
·
,
US
Class A
FDA 510(k)
K183555
Active
Cleared 16 Feb 2019
FDA 510(k)
K183546
Active
Cleared 16 Feb 2019
+4
authorizations
Electrolytes Analyzer
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
Hemo Oxygen Parameter 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
Blood Gas Electrolyte Analyzer
Shenzhen Cornley Bio-Medical Co., Ltd.
·
,
CN
Class A
CE/IVDR
Coagulation Analyzer
Zhejiang Pushkang Biotechnology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Blood Gas & 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 and Chemistry Analyzer
Edan Instruments, Inc.
·
,
CN
IVD General
CE/IVDD
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