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Sources: EU EUDAMED, US FDA
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Country: China
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MDF Instruments Medifriend Inc.
Manufacturer
🇨🇳 China·1 Importer
MDF Instruments Medifriend Inc.
FDA registration
MDF Instruments Medifriend Inc.·13 products·🇨🇳 China
Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR)
Device
EU IVDD
·
Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market
Erythrocyte Osmotic Fragility (EOF) Assay Kit (One-Tube Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device
Rapid identification Kit for B.1.1.7/B.1.351 and P.1 of SARS-CoV-2 (ARMS-PCR)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
GENETIC TESTS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
HER-2/NEU (BREAST CANCER)
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
INFLUENZA A AND /OR B - RT & POC
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
GENETIC TESTS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
K-RAS
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
Device
EU IVDD
·
Eu Ivd General
·Gold Probe Diagnostic Biotechnology Inc. MF·On the market
OrbusNeich Medical (Shenzhen) Co.,Ltd
Manufacturer
🇨🇳 China·1058 Basic UDI-DIs·1058 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.