29 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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SHANGHAI BING FAN INDUSTRIAL CO.,LTD.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device
SHANGHAI BING FAN INDUSTRIAL CO.,LTD.
FDA registration
SHANGHAI BING FAN INDUSTRIAL CO.,LTD.·5 products·🇨🇳 China
Jiangsu Province Huaxing Medical Apparatus Industry Co., Ltd.
Manufacturer
🇨🇳 China·1 Importer
SHEN ZHEN SHI FAN FEN SHU TECHNOLOGY CO., LTD.
FDA registration
SHEN ZHEN SHI FAN FEN SHU TECHNOLOGY CO., LTD.·1 product·🇨🇳 China
Solawave 2-in-1 Skincare Mini (Model: 61043)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Thrive 2-in-1 Breast Pump (Model P3)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Magic Gel
Device
EU MDR
·
Eu Md Class 1
·SHANGHAI BING FAN INDUSTRIAL CO.,LTD.·On the market·4 countries
2-in-1 Abdominal Muscle Training & Back Pain Relief System
FDA 510(k)
FDA Class 2
·Neurology
2-IN-1 COVID-19 Antigen Rapid Test Device (Nasal&Saliva)
Device
EU IVDD
·
Eu Ivd General
·Hangzhou Cybereagen Biotech Co., Ltd.·On the market
2-IN-1 COVID-19 Antigen Rapid Test Device (swab)
Device
EU IVDD
·
Eu Ivd General
·Hangzhou Cybereagen Biotech Co., Ltd.·On the market
2-IN-1 COVID-19 Antigen Rapid Test Device (swab)
Device
EU IVDD
·
Eu Ivd General
·Hangzhou Realy Tech Co.,Ltd.·On the market
2-IN-1 COVID-19 Antigen Rapid Test Device（Nasal&Saliva）
Device
EU IVDD
·
Eu Ivd General
·Hangzhou Realy Tech Co.,Ltd.·On the market
Internal Defib Paddles(2 in with button)
Basic UDI-DI
EU MDD
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Eu Md Class 3
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·1 device
Internal Defib Paddles(3 in with button)
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·1 device
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
FDA Enforcement
Class I
·Completed·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD·June 9, 2021
3 IN 1 HOT OR COLD GEL PACK
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Wuhan Pakcare Bio‐technology Co.,Ltd.·1 device
Hot cold pack
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·SHANGHAI BING FAN INDUSTRIAL CO.,LTD.·1 device
Mission Cholesterol Test Device 3-in-1 Lipid Panel
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Acon Biotech (Hangzhou) Co., Ltd.·1 device
Mission Cholesterol Test Device 3-in-1 Lipid Panel
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Acon Biotech (Hangzhou) Co., Ltd.·1 device
QUIK-CHECK Cholesterol Test Device 3-in-1 Lipid Panel
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Acon Biotech (Hangzhou) Co., Ltd.·1 device