483 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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ICG Electrode
Device
EU MDR
·
Eu Md Class 1
·Shenzhen Med-link Electronics Tech Co., Ltd. ·On the market
4K NIR/ICG Image Processing System
Device
EU MDR
·
Eu Md Class 1
·Zhejiang Healnoc Technology CO., LTD·On the market·6 countries
4K NIR/ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Scivita 4KINSIGHT ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ICG Electrode
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Shenzhen Med-link Electronics Tech Co., Ltd. ·1 device
Mycoplasma Pheumonia IgG (MP IgG) Detection Kit(CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
Helicobacter Pylori IgG (HP IgG) Detection Kit(CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
FDA Enforcement
Class I
·Completed·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD·June 9, 2021
Toxoplasma gondii IgG Avidity（CLIA）、Toxo IgG Avidity Control
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·10 devices
iFlash-Cardiolipin IgG
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN YHLO BIOTECH CO., LTD.·1 device
iFlash-PCNA IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·SHENZHEN YHLO BIOTECH CO., LTD.·2 devices
iFlash-CenpB IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·SHENZHEN YHLO BIOTECH CO., LTD.·2 devices
iFlash-Sp100 IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·SHENZHEN YHLO BIOTECH CO., LTD.·2 devices
Sharay IgG (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·C-Luminary Biotechnology Co., Ltd.·1 device
Sharay IgG (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·C-Luminary Biotechnology Co., Ltd.·1 device
Sharay IgG (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·C-Luminary Biotechnology Co., Ltd.·1 device
Sharay IgG (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·C-Luminary Biotechnology Co., Ltd.·1 device
dsDNA IgG Control
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·SHENZHEN EVER-BLUE BIOTECH CO., LTD.·1 device
Cardiolipin IgG Control
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·SHENZHEN EVER-BLUE BIOTECH CO., LTD.·1 device
Immunoglobulin G (IgG)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device