Manufacturer's Devices - BIONEER Corporation

Address:




8-11 Munpyeongseo-ro



Daedeok-gu

Daejeon 34302

South Korea


Authorised Representative/ UK Responsible Person
Name: MT Promedt Consulting Ltd
Address:

Beaver House 23-38 Hythe Bridge Street



Oxford

OX1 2EP

England United Kingdom




Code/Term Type
HIV1 nucleic acid IVD kit nucleic acid technique (NAT)HIV1 nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT)Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Thermal cycler nucleic acid amplification analyser IVD laboratoryThermal cycler nucleic acid amplification analyser IVD laboratoryIVD General
Nucleic acid sample preparation instrument IVDNucleic acid sample preparation instrument IVDIVD General
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDIVD General