15 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Incubation Chamber ICE-100E
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
Blood Glucose Monitoring Systems (Blood Glucose Meter, Test Strip)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
Incubation Chamber
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
FLI-600 FIA Analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
CLi-1600 Chemiluminescence Immunoassay Analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
FIA Analyzer FLI-100
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Xiamen Biotime Biotechnology Co., Ltd.·3 devices
Blood Cholesterol Monitoring Systems (Blood Cholesterol Meter, Test Strip)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
Digital Pregnancy Tests
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
Hemoglobin Test Strips and Hemoglobin Meter
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
Phencyclidine （PCP） Rapid Test（Urine）
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
PLGF Rapid Quantitative Test (Chemiluminescence Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
Automated Nucleic Acid Extraction System (Mole Fast96)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Jiangsu Mole Bioscience Co., LTD.·1 device
Automated Nucleic Acid Extraction System (Mole 96M)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Jiangsu Mole Bioscience Co., LTD.·1 device
Automated Nucleic Acid Extraction System (Mole 32M)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Jiangsu Mole Bioscience Co., LTD.·1 device