Manufacturer's Devices - BGI Europe A/S

Address:




Ole Maal√łes Vej 3



Copenhagen

DK-2200

Denmark


Authorised Representative/ UK Responsible Person
Name: SUNGO Certification Company Limited
Address:

3rd Floor 70 Gracechurch Street



London

EC3V 0HR

England United Kingdom




Code/Term Type
Human genomic analysis interpretive softwareHuman genomic analysis interpretive softwareIVD Annex II List B
Nucleic acid library construction kit IVDNucleic acid library construction kit IVDIVD Annex II List B
Human papillomavirus (HPV) nucleic acid IVD kit nucleic acid technique (NAT)Human papillomavirus (HPV) nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Nucleic acid extraction/isolation kit IVDNucleic acid extraction/isolation kit IVDIVD General
Evacuated blood collection tube transport container IVDEvacuated blood collection tube transport container IVDIVD General
Human infectome analysis interpretive software IVDHuman infectome analysis interpretive software IVDIVD General
SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Cancer-related multiple gene mutation/mRNA expression IVD kit nucleic acid technique (NAT)Cancer-related multiple gene mutation/mRNA expression IVD kit nucleic acid technique (NAT)IVD General
Human genomic analysis interpretive software IVDHuman genomic analysis interpretive software IVDIVD General
Colorectal cancer genotyping IVD kit nucleic acid technique (NAT)Colorectal cancer genotyping IVD kit nucleic acid technique (NAT)IVD General