3,408 results
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11ms
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Sources: EU EUDAMED, US FDA
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