387 results
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9ms
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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
Xiamen Wiz Biotech Co., Ltd.
Manufacturer
🇨🇳 China·4 Basic UDI-DIs·4 Devices·1 Importer
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
Hefei C&P Nonwoven Products Co.,Ltd
Manufacturer
🇨🇳 China·2 Basic UDI-DIs·2 Devices·4 Importers·TÜV Rheinland LGA Products GmbH
Shandong Jinlai Huanhai Medical Technology Co., Ltd.
Manufacturer
🇨🇳 China·TÜV Rheinland LGA Products GmbH
FARSTAR MEDICAL HUBEI LTD.
Manufacturer
🇨🇳 China·3 Basic UDI-DIs·15 Devices·TÜV Rheinland LGA Products GmbH
Grand Work Plastic Products Co., Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·15 Devices·1 Importer·TÜV Rheinland LGA Products GmbH
Zybio Inc.
Manufacturer
🇨🇳 China·147 Basic UDI-DIs·212 Devices·3 Importers
Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer
🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.
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
RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
Device
EU IVDD
·
Eu Ivd General
·Xiamen Wiz Biotech Co., Ltd.·On the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd General
·Xiamen Wiz Biotech Co., Ltd.·On the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd General
·Xiamen Wiz Biotech Co., Ltd.·On the market
INFLUENZA A AND /OR B - RT & POC
Device
EU IVDD
·
Eu Ivd General
·Xiamen Wiz Biotech Co., Ltd.·On the market
Z3
Device
EU IVDR
·
Eu Ivd Class B
·Zybio Inc.·On the market·1 country