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VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

Device
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

VIROLOGY - NA REAGENTS - OTHER

Device
EU IVDD · Eu Ivd General ·Daan Gene Co., Ltd.·On the market

Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)

Device
EU IVDD · Eu Ivd General ·BioDetect(Xiamen)Biotechnology Co., Ltd.·On the market

DP360 Slide Stainer

Device
EU IVDR · Eu Ivd Class A ·Dakewe (Shenzhen) Medical Equipment Co., Ltd.·On the market·32 countries

SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

SHANGHAI ZJ BIO-TECH CO., LTD

Manufacturer
🇨🇳 China·297 Basic UDI-DIs·326 Devices·2 Importers·TÜV Rheinland LGA Products GmbH

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.

Analysis Software for PCR-Fluorescence Detection Data

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

Detection Kit for 2019-nCoV (PCR-Fluorescence)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Daan Gene Co., Ltd.·1 device

Changsha Sinocare Inc.

Manufacturer
🇨🇳 China·67 Basic UDI-DIs·68 Devices·1 Importer·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Changsha Sinocare Inc.

Manufacturer
🇨🇳 China·1 Importer·TÜV Rheinland LGA Products GmbH

25-HYDROXYVITAMIN D

Device
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

25-HYDROXYVITAMIN D

Device
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

INFLUENZA & PARA INFLUENZA - NA REAGENTS

Device
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

CAMPYLOBACTER DETECTION BY NA REAGENTS

Device
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

CAMPYLOBACTER DETECTION BY NA REAGENTS

Device
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

CAMPYLOBACTER DETECTION BY NA REAGENTS

Device
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

H. PYLORI DETECTION BY NA REAGENTS

Device
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

H. PYLORI DETECTION BY NA REAGENTS

Device
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market