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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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Digital laboratory microscopes
Digital laboratory microscopes
W0202050304
113 devices
Mgu-30009
Grundium Oy
·
,
Finland
Class A
CE/IVDR
PANNORAMIC MIDI II Digital Scanner
3DHISTECH Kft.
·
,
Hungary
IVD General
CE/IVDD
VS200-Bu-V2-Ivd
Evident Technology Center Europe GmbH
·
,
Germany
Class A
CE/IVDR
Automated Hematology Slide Preparation Unit SP-50
Sysmex Corporation
·
,
Japan
Class A
CE/IVDR
Epredia E1000 Dx Digital Pathology Solution
Shandon Diagnostics Limited
·
,
United Kingdom
Class A
FDA 510(k)
K241717
Active
Cleared 28 Feb 2025
CE/IVDR
+1
authorizations
Karotyping and FISH Capture Workstations
Leica Biosystems Imaging, Inc.
·
,
United States
Class A
CE/IVDR
Vs-M1-Ivd
Evident Corporation
·
,
Japan
Class A
CE/IVDR
Solo Server with License for 10 Concurrent User
BioView Ltd.
·
,
Israel
Class A
CE/IVDR
OptraSCAN Digital Pathology System
OptraSCAN Inc.
·
,
United States
Class A
CE/IVDR
VS200-Bu-L-V2-Ivd
Evident Technology Center Europe GmbH
·
,
Germany
Class A
CE/IVDR
Tissuescope LE120
Huron Technologies International Inc.
·
,
Canada
Class A
CE/IVDR
Pathology Scanner SG60i 1.x IVD
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class A
CE/IVDR
Encore
BioView Ltd.
·
,
Israel
Class A
CE/IVDR
Karyo Station with Camera (without Microscope)
Leica Biosystems Imaging, Inc.
·
,
United States
Class A
CE/IVDR
Philips IntelliSite Pathology Solution 6.x - IVDR
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class A
CE/IVDR
GUDID
on market
Aperio GT 180 DX
Leica Biosystems Imaging, Inc.
·
,
United States
Class A
CE/IVDR
PANNORAMIC 250 Flash III DX Digital Scanner
3DHISTECH Kft.
·
,
Hungary
Class A
CE/IVDR
GSL Workstation for BF
Leica Biosystems Imaging, Inc.
·
,
United States
Class A
CE/IVDR
Karotyping Capture Workstation
Leica Biosystems Imaging, Inc.
·
,
United States
Class A
CE/IVDR
Vs-M1-Ivd
Evident Corporation
·
,
Japan
Class A
CE/IVDR
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