25 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: China
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Belle Healthcare Technology Co., Ltd.
Manufacturer
🇨🇳 China
Belle Healthcare Technology Co., Ltd.
FDA registration
Belle Healthcare Technology Co., Ltd.·20 products·🇨🇳 China
ALL ABOUT INSPIRED COMPANY LIMITED
FDA registration
ALL ABOUT INSPIRED COMPANY LIMITED·12 products·🇨🇳 China
ALL-CERAMIC ZIRCONIA BLOCK
FDA 510(k)
FDA Class 2
·Dental
All-in-One Health Monitor, PC-303
FDA 510(k)
FDA Class 2
·Cardiovascular
Well Lead All Silicone Foley Catheter with Temperature Sensor
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)
FDA 510(k)
FDA Class 2
·Dental
Cover All、Split Cover All、Type Cover All
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Leboo Healthcare Products Limited·5 devices
Vacuum Bells
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Guangzhou T.K Medical instrument Co., Ltd.·9 devices
All Sizes
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Suzhou Sunmed Co.,Ltd.·2 devices
Alkaline phosphatase Kit (IFCC Modified Method)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
all in one monitor
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Nanjing Kaiying Intelligent Medical Technology Co., Ltd·1 device
all in one monitor
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Nanjing Kaiying Intelligent Medical Technology Co., Ltd·1 device
Postpartum Catch-All Pads
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Linqing HeTaiDa Medical Technology Co., Ltd·1 device
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
FDA Enforcement
Class I
·Ongoing·Jiangsu Well Biotech Co.,Ltd.·October 19, 2022
All Purpose Gel Pack (x2)
Basic UDI-DI
EU MDD
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Eu Md Class 1
·Wuhan Pakcare Bio‐technology Co.,Ltd.·1 device
All-in-one Molecular Diagnosis System
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Xi'an Tianlong Science and Technology Co., Ltd.·1 device
all-in-on endoscope camera system
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Wuzhou Aokace Technology Co., Ltd.·1 device
All-in-one Digital PCR Device
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Suzhou Sniper Medical Technologies Co., Ltd.·1 device
Zirconia ceramic blocks for all ceramic dentures
Basic UDI-DI
EU MDR
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Eu Md Class 2a
·HUNAN CERAMASTER MATERIAL TECHNOLOGY CO.,LTD·8 devices