11 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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Oxygen Concentrator (J5A)
FDA 510(k)
FDA Class 2
·Anesthesiology
Shen Jia Yi Optical (Shenzhen) Ltd
FDA registration
Shen Jia Yi Optical (Shenzhen) Ltd·1 product·🇨🇳 China
DONG GUAN JIA SHUAN INDUSTRIAL CO., LTD
FDA registration
DONG GUAN JIA SHUAN INDUSTRIAL CO., LTD·4 products·🇨🇳 China
Jiangmen Jia Mei Medical Products Co., Ltd.
FDA registration
Jiangmen Jia Mei Medical Products Co., Ltd.·8 products·🇨🇳 China
SU ZHOU HUI JIA TEXTILES CORPORATION LIMITED
FDA registration
SU ZHOU HUI JIA TEXTILES CORPORATION LIMITED·2 products·🇨🇳 China
LATEX EXAMINATION / TREATMENT GLOVES
Device
EU MDR
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Eu Md Class 1
·Guangzhou Jia Ming Rubber Products Co., LTD·On the market·32 countries
Vertebroplasty auxiliary instrument
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Chongqing FWS Medical Device Co.,Ltd·1 device
Latex gloves
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Guangzhou Jia Ming Rubber Products Co., LTD·1 device
JFA Medical Wound Closure Strips 3mmx75mm, 5 strips per pouch - single pouch
Basic UDI-DI
EU MDD
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Eu Md Class 1
·Suzhou Sunmed Co.,Ltd.·1 device
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk.
FDA Enforcement
Class II
·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·July 15, 2020
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
FDA Enforcement
Class II
·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·March 10, 2021