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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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Various processing instruments for hystology / cytology
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Various processing instruments for hystology / cytology - other
Various processing instruments for hystology / cytology - other
W0202059099
83 devices
Devices
LensHooke® Semen Analysis System
Bonraybio Co., Ltd.
·
,
TW
Class A
FDA 510(k)
K242388
Active
Cleared 9 May 2025
CE/IVDR
Tissue embedding mold 24 x 24 x 7 mm
Lab Path Experts Paweł Piotrowski
·
,
PL
Class A
CE/IVDR
Slide Dryer(Water Bath&Slide Dryer)
Guangzhou Xiuwei Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Automatic Special Staining Machine
Hunan Lituo Biotechnology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Cervical Brush
Kolplast Ci Ltda
·
,
BR
Class I
CE/MDR
Digital Slide Scanner for Pathology
Suzhou Betrue Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Tissue Flotation Water Bath/Tissue Slide Dryer
Infitek Co., Ltd.
·
,
CN
Class A
CE/IVDR
Cold Plate
Guangdong Jinquan Medical Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Liquid-based Cytology Smear Processor
Zhuhai Lituo Biotechnology Co., Ltd.
·
,
CN
Class A
CE/IVDR
CYTOfast Plus
Hospitex International S.r.l.
·
,
IT
Class A
CE/IVDR
Tissue embedding mold 24 x 36 x 7 mm
Lab Path Experts Paweł Piotrowski
·
,
PL
Class A
CE/IVDR
Water Bath
Guangzhou Xiuwei Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
LBC Medium
bioBoaVista
·
,
BR
Class A
CE/IVDR
PathTezt Processor 2000
Biocytech Corporation Sdn. Bhd.
·
,
MY
Class A
CE/IVDR
LBP Auto-Coverslipper
Guangzhou LBP Medicine Science & Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Digital Slide Scanner for Pathology
Suzhou Betrue Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Aerospray® Cytology Stain F Empty Bottle w/Level Detect
Elitechgroup Inc.
·
,
US
Class A
CE/IVDR
GUDID
on market
Digital Slide Scanner for Pathology
Guangzhou LBP Medicine Science & Technology Co., Ltd.
·
,
CN
Class A
CE/IVDR
Liquid-based Cytology Smear Processor
Zhuhai Lituo Biotechnology Co., Ltd.
·
,
CN
Class A
CE/IVDR
PathTezt Processor
Biocytech Corporation Sdn. Bhd.
·
,
MY
Class A
CE/IVDR
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