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In vitro diagnostic medical devices
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IVD instruments
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Hematology / histology / cytology instruments
Hematology / histology / cytology instruments
W0202
3,904 devices
Subcategories
7
W020201
Haematology / cell counting
596
devices
›
W020202
Hemostasis
503
devices
›
W020203
Blood grouping instruments
78
devices
›
W020204
Flow cytometry instruments
185
devices
›
W020205
Histology / cytology
2,260
devices
›
W020206
Rapid test hematology / histology / cytology instruments
53
devices
›
W020290
Various hematology / histology /cytology instruments
229
devices
›
Devices
ADAM-rWBC HT
NanoEnTek, Inc.
·
,
South Korea
Class A
CE/IVDR
GUDID
on market
Auto Hematology Analyzer Ox 560 - Ret
Gmt SARL
·
,
France
IVD General
CE/IVDD
sthemA 601
Tcoag ireland ltd
·
,
Ireland
Class B
CE/IVDR
Auto Hematology Analyzer
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
Automatic Hematology Analyzer
Shenzhen Comen Medical Instruments Co., LTD.
·
,
China
IVD General
CE/IVDD
Pentra XLR
Horiba Abx
·
,
France
Class B
FDA 510(k)
K151133
Active
Cleared 9 Dec 2015
CE/IVDR
+1
authorizations
Hematology Analyzer
Edan Instruments, Inc.
·
,
China
Class B
CE/IVDR
Automatic Hematology Analyzer
Changsha Han Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Yumizen H500 OT
Horiba Abx
·
,
France
Class B
CE/IVDR
Multifunctional blood analyzer
Shenzhen Zijian Biotechnology Co., Ltd
·
,
China
Class A
CE/IVDR
Yumizen H500E OT
Horiba Abx
·
,
France
Class B
CE/IVDR
Auto Hematology Analyzer
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
BH-5380CRP 5-Part-Diff Auto Hematology Analyzer
URIT Medical Electronic Co., Ltd.
·
,
China
Class B
CE/IVDR
TruCell
BioFynder Limited
·
,
United Kingdom
Class A
CE/IVDR
Cellagon 5 Pro Hematology Analyzer
Diagon Diagnosztikai Korlátolt Felelősségű Társaság
·
,
Hungary
Class A
CE/IVDR
Merilyzer LumiQuant™ LQ100
Meril Diagnostics Pvt. Ltd.
·
,
India
Class A
CE/IVDR
Auto Hematology Analyzer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
HemoScreen
Pixcell Medical Ltd.
·
,
Israel
Class B
CE/IVDR
×2
Active
Valid to Nov 2029
GUDID
on market
Auto Hematology Analyzer
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
Hematology Analyzer
Nanjing Poweam Medical Co., Ltd
·
,
China
Class A
CE/IVDR
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