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Shenzhen Huian Biosci Technology Co., Ltd.

Manufacturer
🇨🇳 China·6 Basic UDI-DIs·6 Devices·CeCert Sp. z o.o.

Hangzhou Laihe Biotech Co., Ltd.

Manufacturer
🇨🇳 China·6 Basic UDI-DIs·6 Devices·2 Importers·CeCert Sp. z o.o. and TÜV Rheinland LGA Products GmbH

VIROLOGY - RT & POC - OTHER

Device
EU IVDD · Eu Ivd Self Testing ·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries

VIROLOGY - RT & POC - OTHER

Device
EU IVDD · Eu Ivd Self Testing ·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries

VIROLOGY - RT & POC - OTHER

Device
EU IVDD · Eu Ivd Self Testing ·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries

VIROLOGY - RT & POC - OTHER

Device
EU IVDD · Eu Ivd Self Testing ·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries

VIROLOGY - RT & POC - OTHER

Device
EU IVDD · Eu Ivd Self Testing ·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries

VIROLOGY - RT & POC - OTHER

Device
EU IVDD · Eu Ivd Self Testing ·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries

LYHER

Device
EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·On the market

COVID-19 and Influenza A/B Antigen Test Kit for self-testing

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·1 device

SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

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

SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

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

SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

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

SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

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

SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

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

SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

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

Cofoe Medical Technology Co.,Ltd.

Manufacturer
🇨🇳 China·38 Basic UDI-DIs·54 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Hangzhou Singclean Medical Products Co., Ltd.

Manufacturer
🇨🇳 China·149 Basic UDI-DIs·149 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

CeCert/068/W/E.2

Certificate
IVDD Annex III Section 6·Hangzhou Laihe Biotech Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

CeCert/126/W/E.1

Certificate
IVDD Annex III Section 6·Shenzhen Huian Biosci Technology Co., Ltd.·CeCert Sp. z o.o.·6 Basic UDI-DIs