Total Triiodothyronine Kit (Microfluidic Fluorescent Immunoassay)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Hunan Kangxin Biotechnology Co., Ltd.·1 device

Thyroid Stimulating Hormone Kit (Microfluidic Fluorescent Immunoassay)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Hunan Kangxin Biotechnology Co., Ltd.·1 device

Meridius Medical Europe Limited

Authorized representative

🇮🇪 Ireland·36 Manufacturers·720 Devices

TK Biotech Sp. z o.o.

Importer

🇵🇱 Poland·10 Manufacturers

1434-IVDD-198/2022

Certificate

IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-199/2022

Certificate

IVDD Annex IV (excluding sections 4, 6)·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·1 device

DGM-0549

Certificate

IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·1 Basic UDI-DI

DGM-459

Certificate

IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·2 Basic UDI-DIs

DGM-458

Certificate

IVDD Annex IV Section 4·bioLytical Laboratories Inc.·Presafe Denmark A/S·1 Basic UDI-DI

DGM-549

Certificate

IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·31 Basic UDI-DIs

DGM-548

Certificate

IVDD Annex IV Section 4·bioLytical Laboratories Inc.·Presafe Denmark A/S·33 Basic UDI-DIs

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

iSTATIS COVID-19 Ag HOME TEST

Basic UDI-DI

EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

iSTATIS COVID-19 Ag HOME TEST

Basic UDI-DI

EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

iSTATIS COVID-19 Ag TEST

Basic UDI-DI

EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

INSTI COVID ANTIBODY TEST

Basic UDI-DI

EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·1 device

INSTI HIV ANTIBODY SELF-TEST

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

INSTI HCV CONTROL TEST KIT

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device

INSTI HIV ANTIBODY SELF-TEST

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·1 device