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In vitro diagnostic medical devices
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IVD instruments
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Hematology / histology / cytology instruments
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Various hematology / histology /cytology instruments
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Various hematology / histology / cytology instruments - other
Various hematology / histology / cytology instruments - other
W02029099
66 devices
Anti-Streptolysin O [ASO]
Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
·
,
Türkiye
IVD General
CE/IVDD
SeekOne™ Digital Droplet System
Beijing SeekGene BioSciences Co., Ltd
·
,
China
Class A
CE/IVDR
Hemonitor H1
Genbody Inc.
·
,
South Korea
Class B
CE/IVDR
IX 2631406-1
Active
Valid to Oct 2030
Citotest
Citotest Labware Manufacturing Co., Ltd
·
,
China
Class I
CE/MDR
Anti-Streptolysin O [ASO] Kit
Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
·
,
Türkiye
IVD General
CE/IVDD
Anti-Streptolysin O [ASO] Kit
Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
·
,
Türkiye
IVD General
CE/IVDD
Fully Automated CLIA Analyzer
C-Luminary Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
CellaVision® DC-1
Cellavision AB
·
,
Sweden
Class A
FDA 510(k)
K200595
Active
Cleared 16 Oct 2020
CE/IVDR
+1
authorizations
Mr
Mr International Healthcare Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Liquid-based Thin-layer cytology processor
Hangzhou Yiguoren Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Automated System for Liquid Based Cell Preparation, Staining and Sealing
Motic (Xiamen) Medical Diagnostic Systems Co., Ltd
·
,
China
Class A
CE/IVDR
Glycated Hemoglobin Analyzer HAM111
Beijing Lepu Medical Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Liquid-Based Thin-layer Cytology Processor
Hangzhou Yiguoren Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Anti-Streptolysin O [ASO] Kit
Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
·
,
Türkiye
IVD General
CE/IVDD
Mr
Mr International Healthcare Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Blood Glucose, Ketone and Uric Acid Meters
Beijing Lepu Medical Technology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Automated Digital Cell Morphology Analyzer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Digital Slide Scanning & Imaging System
Hunan Lituo Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Digital Slide Scanning & Imaging System
Hunan Lituo Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Fully automatic dynamic erythrocyte sedimentation rate analyzer
Jiangsu Hongen Medical Devices Co., Ltd.
·
,
China
Class A
CE/IVDR
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