7,061 results · 59ms · Sources: EU EUDAMED, US FDA

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INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]

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

INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]

Device
EU IVDD · Eu Ivd General ·Hunan Kangxin Biotechnology Co., Ltd.·On the market·32 countries

INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]

Device
EU IVDD · Eu Ivd General ·KH Medical Co., Ltd.·On the market

Over-The-Counter Covid-19 Antigen Test

FDA classification
FDA Class 2 ·Over-The-Counter Covid-19 Antigen Test

Tap or Knob Turner

FDA registration
Zengcheng Hua Chang Plastic & Metal Moulding Company Limited·1 product·🇨🇳 China

Fork Queens handle

FDA registration
Zengcheng Hua Chang Plastic & Metal Moulding Company Limited·1 product·🇨🇳 China

Nanox.ARC

FDA registration
Dagesh F.K. Ltd.·2 products·🇮🇱 Israel

Sonaris

FDA registration
Zengcheng Hua Chang Plastic & Metal Moulding Company Limited·1 product·🇨🇳 China

Savanah Splash Guard

FDA registration
Zengcheng Hua Chang Plastic & Metal Moulding Company Limited·1 product·🇨🇳 China

Nanox.ARC

FDA registration
Dagesh F.K. Ltd.·2 products·🇮🇱 Israel

Brevetti stocking and sock aid

FDA registration
Zengcheng Hua Chang Plastic & Metal Moulding Company Limited·1 product·🇨🇳 China

Grab Rail Plastic Fluted White

FDA registration
Zengcheng Hua Chang Plastic & Metal Moulding Company Limited·1 product·🇨🇳 China

Covid-19 Test Home Collection Kit Devices

FDA classification
FDA Not Classified ·Covid-19 Test Home Collection Kit Devices

SARS-CoV-2 Antigen Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Hangzhou Alltest Biotech.Co.,Ltd.·1 device

SARS-CoV-2 Ag Duo Home

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

SARS-CoV-2 Antigen Rapid Test

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

MERS-CoV Real Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

MERS-CoV Real Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

SARS-CoV Real Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

SARS-CoV Real Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device