22 results · 17ms · Sources: EU EUDAMED, US FDA

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Daan Gene Co., Ltd.

Manufacturer
🇨🇳 China·127 Basic UDI-DIs·194 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.

Sansure Biotech Inc.

Manufacturer
🇨🇳 China·1252 Basic UDI-DIs·1376 Devices·4 Importers·TÜV SÜD Product Service GmbH, CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Assure Tech. (Hangzhou) Co., Ltd.

Manufacturer
🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market·3 countries

Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market

HEPATITIS C VIRUS - NA REAGENTS

Device
EU IVDD · Eu Ivd Annex 2 List A ·Daan Gene Co., Ltd.·On the market

HEPATITIS B VIRUS - NA REAGENTS

Device
EU IVDD · Eu Ivd Annex 2 List A ·Daan Gene Co., Ltd.·On the market

HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

Device
EU IVDD · Eu Ivd Annex 2 List A ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Diagnostic Kit for Quantification of Hepatitis C Virus RNA (PCR -Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Daan Gene Co., Ltd.·1 device

Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Daan Gene Co., Ltd.·1 device

HIV Rapid Test Device (Whole blood/Serum/Plasma)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

CeCert/077/W/E.1

Certificate
IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

CeCert/115/W/E.1

Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

CeCert/117/W/E.1

Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

CeCert/119/W/E.1

Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

CeCert/042/W/E.1

Certificate
IVDD Annex IV Section 4·Daan Gene Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI