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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
GS1800-B
Gruppo Strola srl
·
,
Italy
Class A
CE/IVDR
Aura 10 Pet-Ct
Xeos Medical
·
,
Belgium
Class A
FDA 510(k)
K231420
Active
Cleared 10 Aug 2023
CE/IVDR
+1
authorizations
Fluorometer
Hangzhou Allsheng Instruments Co., Ltd
·
,
China
Class A
CE/IVDR
AutoBlot System 48
MP Biomedicals Asia Pacific Pte Ltd
·
,
Singapore
Class A
CE/IVDR
Spectrophotometer
Infitek Co., Ltd.
·
,
China
Class A
CE/IVDR
Lipidica 1.0
Lipidica, a.s.
·
,
Czechia
IVD General
CE/IVDD
Phadia-250 Connector to CCM (PCM2)
Hitachi High-Tech Corporation
·
,
Japan
Class A
CE/IVDR
ThEA RapiDx
RAM THz Solutions GmbH
·
,
Germany
IVD General
CE/IVDD
Citotest
Citotest Labware Manufacturing Co., Ltd
·
,
China
Class I
CE/MDR
Biochemistry Analyzer
Nanjing Poweam Medical Co., Ltd
·
,
China
Class A
CE/IVDR
Citotest
Citotest Labware Manufacturing Co., Ltd
·
,
China
Class I
CE/MDR
Orbital Shaker
Hangzhou Allsheng Instruments Co., Ltd
·
,
China
Class A
CE/IVDR
Citotest
Citotest Labware Manufacturing Co., Ltd
·
,
China
Class I
CE/MDR
Specimen Radiography System
CompAI MedTech (Suzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
Citotest
Citotest Labware Manufacturing Co., Ltd
·
,
China
Class I
CE/MDR
Dry Bath Incubator
Hangzhou Allsheng Instruments Co., Ltd
·
,
China
Class A
CE/IVDR
Nucleic Acid Extraction and Purification System MGISP-100B
Wuhan MGI Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
GS1500-11015-F-B
Gruppo Strola srl
·
,
Italy
Class A
CE/IVDR
Dry Fluorescence Immunoassay Analyzer
Lansion Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Fluorescent Immunoassay Analyzer
Hunan Kangxin Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
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