10,000 results · 52ms · Sources: EU EUDAMED, US FDA

Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR)

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Non-Invasive Fetal Trisomy (NIFTY) Test Sample Collection Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·1 device

SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·BGI EUROPE A/S·1 device

Nucleic Acid Extraction Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·2 devices

Free β Human Chorionic Gonadotropin (F-β-HCG) Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Carcino-embryonic antigen(CEA)Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Carcino-embryonic antigen(CEA)Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Carcino-embryonic antigen(CEA)Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Carcino-embryonic antigen(CEA)Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Fecal Occult Blood (FOB) Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Fecal Occult Blood (FOB) Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Fecal Occult Blood (FOB) Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Fecal Occult Blood (FOB) Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Alpha fetoprotein Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Alpha fetoprotein Test (Colloidal Gold)

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Real-time fluorescent RT-PCR kit for detecting 2019-nCoV

Basic UDI-DI
EU IVDD · Eu Ivd General ·BGI EUROPE A/S·1 device

Nucleic Acid Extraction Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·BGI EUROPE A/S·1 device

M.2023.MDR.1012-1

Certificate
MDR QMS·Zrinski Solution GbR·UDEM Adriatic d.o.o.

M.2023.MDR1012-2

Certificate
MDR Technical Documentation·Zrinski Solution GbR·UDEM Adriatic d.o.o.