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Sanway Gene Tech. Inc.

Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Shenzhen Superbio Technology Co.,Ltd.

Manufacturer
🇨🇳 China·589 Basic UDI-DIs·591 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS

Device
EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·On the market·3 countries

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Device
EU IVDD · Eu Ivd Self Testing ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Device
EU IVDD · Eu Ivd Self Testing ·Shenzhen Superbio Technology Co.,Ltd.·On the market

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Device
EU IVDD · Eu Ivd Self Testing ·Shenzhen Superbio Technology Co.,Ltd.·On the market

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

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Shenzhen Superbio Technology Co.,Ltd.·1 device

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Shenzhen Superbio Technology Co.,Ltd.·1 device

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Shenzhen Superbio Technology Co.,Ltd.·1 device

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

1434-IVDD-254/2022

Certificate
IVDD Annex III Section 6·Shenzhen Superbio Technology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs

Microdial Flowmeter - Range E 0.01 - 1 l/min - BS 5682/Barb

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BPR Medical Limited·1 device

Analgesic Demand Valve - 2m Hose - AFNOR connector

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BPR Medical Limited·1 device

Analgesic Demand Valve - 4m Hose - AFNOR connector

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BPR Medical Limited·1 device

Analgesic Demand Valve - 6m Hose - Nordica connector

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BPR Medical Limited·1 device

Analgesic Demand Valve - 3m Hose - Nordica connector

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BPR Medical Limited·1 device

Oxygen Demand Valve - 3m Hose - Nordica Connector AGA mini

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BPR Medical Limited·1 device

Service Exchange - Oxygen Demand Valve - 3m Hose - AGA mini

Basic UDI-DI
EU MDD · Eu Md Class 2a ·BPR Medical Limited·1 device