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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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Histology / cytology
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Laboratory instruments for microscopic investigations
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Laboratory instruments for microscopic investigations - IVD medical device software
Laboratory instruments for microscopic investigations - IVD medical device software
W0202050392
43 devices
Chromosome analysis software
Shenzhen Reetoo Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
PathoZoom® Scan & LiveView
Smart In Media AG
·
,
Germany
Class A
CE/IVDR
Aiforia® Gastric Cancer
Aiforia Technologies Plc
·
,
Finland
Class C
CE/IVDR
Aiforia® Clinical AI Model for Lung Cancer +1 more model
Aiforia Technologies Plc
·
,
Finland
IVD General
CE/IVDD
LUCIA Cytogenetics, version 4.2
Laboratory Imaging s.r.o.
·
,
Czechia
Class C
CE/IVDR
Aiforia® Clinical AI Model for Breast Cancer +1 more model
Aiforia Technologies Plc
·
,
Finland
IVD General
CE/IVDD
Aiforia® Lymph Node Metastasis
Aiforia Technologies Plc
·
,
Finland
Class C
CE/IVDR
Visiocyt Bladder
VitaDX International
·
,
France
Class C
CE/IVDR
ParaScout
Leven Vision B.V.
·
,
Netherlands
Class A
CE/IVDR
PathoZoom® Digital Lab
Smart In Media AG
·
,
Germany
Class A
CE/IVDR
CaloPix 5.2.10
Tribun Health
·
,
France
IVD General
FDA 510(k)
K250414
Active
Cleared 14 May 2025
CE/IVDD
Biosystems Ara
Biosystems S.A.
·
,
Spain
Class A
CE/IVDR
Aiforia® Prostate Cancer Biopsy
Aiforia Technologies Plc
·
,
Finland
Class C
CE/IVDR
Aiforia® Breast Cancer Grading
Aiforia Technologies Plc
·
,
Finland
Class C
CE/IVDR
Visiocyt Bladder
VitaDX International
·
,
France
Class C
CE/IVDR
Mindpeak AI Console
Mindpeak GmbH
·
,
Germany
IVD General
CE/IVDD
Aiforia® Clinical Suite Viewer
Aiforia Technologies Plc
·
,
Finland
Class C
CE/IVDR
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