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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
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Automated 5 part differential hematology analysers
/
Automated whole blood hematology analysers - moderate routine (throughput > 100 and <= 120 samples/hr)
Automated whole blood hematology analysers - moderate routine (throughput > 100 and <= 120 samples/hr)
W0202010102
31 devices
Devices
Auto Hematology Analyzer
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Automatic Hematology Systerm
Dirui Industrial Co., Ltd
·
,
CN
IVD General
CE/IVDD
sthemA 801 / HERA
Arteion S.A.S
·
,
FR
IVD General
CE/IVDR
CE/IVDD
Yumizen H1500 (Yumizen SPS connectable)
Horiba Abx
·
,
FR
Class B
CE/IVDR
Dirui
Dirui Industrial Co., Ltd
·
,
CN
IVD General
CE/IVDD
Yumizen 1500 (Yumizen SPS connectable)
Horiba Abx SAS
·
,
FR
Class B
CE/IVDR
Yumizen H2500
Horiba Abx
·
,
FR
Class B
CE/IVDR
GUDID
on market
5-Part Auto Hematology Analyzer
Shandong Bohong Gene Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Automatic Hematology Systerm
Dirui Industrial Co., Ltd
·
,
CN
IVD General
CE/IVDD
BH-7600CS、BH-7610CS、 BH-7620CS、BH-7630CS、 BH-7660CS、 BH-7680CS、BH-7680、BH-7600 …
URIT Medical Electronic Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Yumizen H2500
Horiba Abx SAS
·
,
FR
Class B
CE/IVDR
Yumizen H2500 (Yumizen SPS connectable)
Horiba Abx
·
,
FR
Class B
FDA 510(k)
K232946
Active
Cleared 21 May 2024
CE/IVDR
+1
authorizations
Yumizen H1500
Horiba Abx SAS
·
,
FR
Class B
CE/IVDR
Yumizen H1500
Horiba Abx SAS
·
,
FR
Class B
CE/IVDR
Yumizen H2500 (Yumizen SPS connectable)
Horiba Abx
·
,
FR
Class B
CE/IVDR
Automatic Hematology Analyzer
Maccura Medical Instrument Co., Ltd.
·
,
CN
IVD General
CE/IVDR
CE/IVDD
Automatic Hematology Systerm
Dirui Industrial Co., Ltd
·
,
CN
IVD General
CE/IVDD
BH-6180 5-Part-Diff Auto Hematology Analyzer
URIT Medical Electronic Co., Ltd.
·
,
CN
Class B
CE/IVDR
Automatic Hematology Analyzer
Genegeo Diagnostics (Jiangsu) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Automatic Hematology Analyzer
Genegeo Diagnostics (Jiangsu) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
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