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In vitro diagnostic medical devices
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IVD instruments
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IVD instruments - other
IVD instruments - other
W0299
631 devices
GS1500-9015-F-S
Gruppo Strola srl
·
,
Italy
Class A
CE/IVDR
Citotest
Citotest Labware Manufacturing Co., Ltd
·
,
China
Class I
CE/MDR
Synergy H1
Agilent Technologies, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
DFB180-X-S
Gruppo Strola srl
·
,
Italy
Class A
CE/IVDR
Automatic Sperm Analyzer(including sperm counting slide &related kits)
Xuzhou Qibo Electronic Technology Co., Ltd
·
,
China
Class A
CE/IVDR
Pathology Image Management System
Winmedic Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
Van Gogh Microscopy System
CellTivity Scientific, Inc.
·
,
United States
Class A
CE/IVDR
Citotest
Citotest Labware Manufacturing Co., Ltd
·
,
China
Class I
CE/MDR
Decomatic
Innovative Biotechnology Organization Trade Limited Company
·
,
Türkiye
Class A
CE/IVDR
cobas universal interface
Hitachi High-Tech Corporation
·
,
Japan
Class A
CE/IVDR
Actim 1ngeni Instrument Check
Actim Oy
·
,
Finland
Class A
CE/IVDR
CCM cobas c513 Connection Unit
Hitachi, Ltd.
·
,
Japan
Class A
CE/IVDR
Homogenizer
Hangzhou Allsheng Instruments Co., Ltd
·
,
China
Class A
CE/IVDR
GS1800-11015-F-S
Gruppo Strola srl
·
,
Italy
Class A
CE/IVDR
Digital Pathology Slide Scanner
Winmedic Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
Citotest
Citotest Labware Manufacturing Co., Ltd
·
,
China
Class I
CE/MDR
Solas OR XL
Cirdan Imaging Ltd
·
,
Northern Ireland
Class A
FDA 510(k)
K213691
Active
Cleared 22 Dec 2021
CE/IVDR
Fully Automatic Immunoblotting Analyser
Guangzhou Kangrun Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Vaginal Secretion Analyzer
Shenzhen Reetoo Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
Citotest
Citotest Labware Manufacturing Co., Ltd
·
,
China
Class I
CE/MDR
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