329 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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SIGNA Creator, SIGNA Explorer, NMRI systems
FDA Enforcement
Class II
·Ongoing·GE Healthcare (China) Co., Ltd.·March 5, 2025
Braincare (Beijing) medical device co. LTD
Manufacturer
🇨🇳 China·2 Basic UDI-DIs·2 Devices
Hangzhou Thales Medtech Co., Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·4 Devices
Lumicare Medtech Co., Ltd.
Manufacturer
🇨🇳 China·2 Basic UDI-DIs·3 Devices·1 Importer
Synaptic Medical Limited
Manufacturer
🇨🇳 China·1 Importer
Hangzhou Micro-inno Medical Technology Co.,Ltd
Manufacturer
🇨🇳 China
GUANGDONG ENNO MEDICAL TECHNOLOGY CO., LTD.
FDA registration
GUANGDONG ENNO MEDICAL TECHNOLOGY CO., LTD.·4 products·🇨🇳 China
PROTECTION DRAPES AND GARMENTS - OTHER
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries
PROTECTION DRAPES AND GARMENTS - OTHER
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries
SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries
BED AND STRETCHER HYGIENIC COVERS
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries
PROTECTION DRAPES AND GARMENTS - OTHER
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries
SURGICAL APRONS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries
NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries
CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries
PROTECTION DRAPES AND GARMENTS - OTHER
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries
STANDARD SURGICAL GOWNS
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries
PROTECTION DRAPES AND GARMENTS - OTHER
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries
PROTECTION DRAPES AND GARMENTS - OTHER
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries
MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS)
Device
EU MDR
·
Eu Md Class 1
·FULLSTAR NON-WOVEN PRODUCTS CO.,LTD·On the market·32 countries