AmoyDx® Tissue DNA Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·1 device

PSA Rapid Test

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

fPSA Rapid Test

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

Colloidal Gold Reader

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

AutoLumo analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·1 device

HIV Self Test

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·1 device

AmoyDx® FFPE DNA Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·1 device

AmoyDx® Circulating DNA Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·1 device

AmoyDx® FFPE RNA Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·1 device

AmoyDx® Blood/Bone Marrow DNA Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·1 device

AmoyDx® Tissue RNA Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·1 device

HIV Self Test

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·1 device

AmoyDx® FFPE DNA/RNA Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Amoy Diagnostics Co., LTD.·1 device

KDHT

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·1 device

EDPO

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·11 devices

EKa(p)DH

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Yelatma Instrument-Making Enterprise Joint-Stock Company·2 devices

B F Mulholland Limited

Authorized representative

1 Manufacturer

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