Shanghai BioGerm Medical Technology Co., Ltd.

Manufacturer

🇨🇳 China·9 Basic UDI-DIs·9 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Manufacturer

🇨🇳 China·192 Basic UDI-DIs·192 Devices·1 Importer·CeCert Sp. z o.o.

Laboratories Hyamed SA

Manufacturer

🇨🇭 Switzerland·3 Basic UDI-DIs·3 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

1434-IVDD-076/2022

Certificate

IVDD Annex III Section 6·Shanghai BioGerm Medical Technology Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs

CeCert/113/W/E.1

Certificate

IVDD Annex III Section 6·Dynamiker Biotechnology (Tianjin) Co., Ltd.·CeCert Sp. z o.o.·2 Basic UDI-DIs

CE-MDD-0082/09/2020/01/DD.01

Certificate

MDD Annex II Section 4·Laboratories Hyamed SA·BSI Group The Netherlands B.V.·3 Basic UDI-DIs

CE-MDD-0082/09/2020/01

Certificate

MDD Annex II (excluding section 4)·Laboratories Hyamed SA·BSI Group The Netherlands B.V.·3 Basic UDI-DIs

BioGerm SARS-CoV-2 Antigen Self Test

Device

EU IVDD · Eu Ivd Self Testing ·Shanghai BioGerm Medical Technology Co., Ltd.·On the market·32 countries

BioGerm SARS-CoV-2 Antigen Self Test

Device

EU IVDD · Eu Ivd Self Testing ·Shanghai BioGerm Medical Technology Co., Ltd.·On the market

BioGerm SARS-CoV-2 Antigen Self Test

Device

EU IVDD · Eu Ivd Self Testing ·Shanghai BioGerm Medical Technology Co., Ltd.·On the market

CORONAVIRUS [obsolete from 2025-01-01]

Device

EU IVDD · Eu Ivd Self Testing ·Dynamiker Biotechnology (Tianjin) Co., Ltd.·On the market

CORONAVIRUS [obsolete from 2025-01-01]

Device

EU IVDD · Eu Ivd Self Testing ·Dynamiker Biotechnology (Tianjin) Co., Ltd.·On the market

Hyamax®

Device

EU MDD · Eu Md Class 3 ·Laboratories Hyamed SA·On the market·32 countries

Hyamax®

Device

EU MDD · Eu Md Class 3 ·Laboratories Hyamed SA·On the market·32 countries

Hyamax®

Device

EU MDD · Eu Md Class 3 ·Laboratories Hyamed SA·On the market·32 countries

BioGerm SARS-CoV-2 Antigen Self Test

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Shanghai BioGerm Medical Technology Co., Ltd.·1 device

BioGerm SARS-CoV-2 Antigen Self Test

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Shanghai BioGerm Medical Technology Co., Ltd.·1 device

BioGerm SARS-CoV-2 Antigen Self Test

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Shanghai BioGerm Medical Technology Co., Ltd.·1 device

Dynamiker SARS-CoV-2 Ag Rapid Test

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device

Dynamiker SARS-CoV-2 Ag Rapid Test

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Dynamiker Biotechnology (Tianjin) Co., Ltd.·1 device