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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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Chemistry instruments
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Limited panel chemistry analysers
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Urine analysers
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Semi-automated urine analysers
Semi-automated urine analysers
W020101020102
67 devices
Devices
PocketChem UA (PU-4010)
ARKRAY Factory, Inc.
·
,
JP
Class A
CE/IVDR
AutionIDaten (AE-4070)
ARKRAY Factory, Inc.
·
,
JP
Class A
CE/IVDR
Urine Analyzer H-500
Dirui Industrial Co., Ltd
·
,
CN
Class A
CE/IVDR
HCU01
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Mr
Mr International Healthcare Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Quik-Check Expert U120 Smart Urine Analyzer
Acon Biotech (Hangzhou) Co., Ltd.
·
,
CN
Class A
CE/IVDR
Urine Analyzer
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class A
CE/IVDR
Semi-Automatic Urine Analyzer
Maccura Medical Instrument Co., Ltd.
·
,
CN
Class A
CE/IVDR
Urine Analyzer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class A
CE/IVDR
HC-300 Urine Analyzer
Dirui Industrial Co., Ltd
·
,
CN
Class A
CE/IVDR
H-100
Dirui Industrial Co., Ltd
·
,
CN
Class A
CE/IVDR
Semi-Automatic Urine Analyzer
Maccura Medical Instrument Co., Ltd.
·
,
CN
Class A
CE/IVDR
Urine Analyzer
URIT Medical Electronic Co., Ltd.
·
,
CN
Class A
FDA 510(k)
K232317
Active
Cleared 26 Apr 2024
CE/IVDR
Urine Analyzer
Biobase Biodustry(Shandong) Co., Ltd.
·
,
CN
Class A
CE/IVDR
GUDID
on market
Urine Analyzer
URIT Medical Electronic Co., Ltd.
·
,
CN
Class A
CE/IVDR
Quik-Check Expert U120 Smart Urine Analyzer
Acon Biotech (Hangzhou) Co., Ltd.
·
,
CN
Class A
CE/IVDR
H-500 Urine Analyzer
Dirui Industrial Co., Ltd
·
,
CN
Class A
CE/IVDR
Urine Analyzer
URIT Medical Electronic Co., Ltd.
·
,
CN
Class A
CE/IVDR
Urine Analyzer H-100
Dirui Industrial Co., Ltd
·
,
CN
Class A
CE/IVDD
CE/IVDR
Mission U500 Urine Analyzer
Acon Biotech (Hangzhou) Co., Ltd.
·
,
CN
Class A
CE/IVDR
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