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.

Cutera, Inc.

Manufacturer

🇺🇸 United States·17 Basic UDI-DIs·21 Devices·2 Importers·TUV NORD Polska Sp. z o.o and TÜV NORD CERT GmbH

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

CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS

Device

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

CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS

Device

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

CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS

Device

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

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

Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Daan Gene Co., Ltd.·1 device

Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Daan Gene Co., Ltd.·1 device

Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Daan Gene Co., Ltd.·1 device

CeCert/043/W/E.1

Certificate

IVDD Annex IV (excluding sections 4, 6)·Daan Gene Co., Ltd.·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

CeCert/045/W/E.1

Certificate

IVDD Annex IV (excluding sections 4, 6)·Daan Gene Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

CeCert/044/W/E.1

Certificate

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

CeCert/072/W/E.1

Certificate

IVDD Annex IV (excluding sections 4, 6)·Daan Gene Co., Ltd.·CeCert Sp. z o.o.·3 Basic UDI-DIs

TNP/MDR/0029/5488/2025

Certificate

MDR QMS·Cutera, Inc.·TUV NORD Polska Sp. z o.o