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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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Haematology / cell counting
Haematology / cell counting
W020201
596 devices
Subcategories
3
W02020101
Automated 5 part differential hematology analysers
374
devices
›
W02020102
Limited panel cell counting analysers
145
devices
›
W02020199
Cell counting instruments - other
77
devices
Devices
BH-40P Automated Hematology Analyzer
URIT Medical Electronic Co., Ltd.
·
,
China
Class B
CE/IVDR
UniCel DxH 800 Coulter Cellular Analysis System
Open recall
Beckman Coulter, Inc.
·
,
United States
IVD General
FDA 510(k)
×4
K081930
Active
Cleared 19 Dec 2008
CE/IVDD
+1
authorizations
Automatic Hematology Analyzer
Seamaty Diagnostic Co., Ltd.
·
,
China
Class A
CE/IVDR
Automatic Hematology Analyzer
Maccura Medical Instrument Co., Ltd.
·
,
China
Class B
CE/IVDR
Auto Hematology Analyzer
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Abacus 5 Hematology Analyzer with SSM
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
·
,
Hungary
Class A
CE/IVDR
Auto Hematology Analyzer
Rayto Life and Analytical Sciences Co., Ltd.
·
,
China
IVD General
CE/IVDD
QBC STAR, Refurbished
Drucker Diagnostics
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Auto Hematology Analyzer
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
Hematology Analyzer
Zybio Inc.
·
,
China
Class B
CE/IVDR
Auto Hematology Analyze
Genrui Biotech Inc.
·
,
China
IVD General
CE/IVDD
Auto Hematology Analyzer
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Auto Hematology Analyzer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Auto Specific Protein and ESR Analyzer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Z-Gem 5
ZOVEC diagnostics GmbH
·
,
Germany
IVD General
CE/IVDD
Auto Hematology Analyzer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
GUDID
on market
QBC Autoread Plus Dry Hematology Analyzer
Drucker Diagnostics
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Hematology Analyzer
Zybio Inc.
·
,
China
Class B
CE/IVDR
Adamii
NanoEnTek, Inc.
·
,
South Korea
Class A
CE/IVDR
GUDID
on market
Auto Hematology Analyzer Ox - 560
Gmt SARL
·
,
France
IVD General
CE/IVDD
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