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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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General medicine diagnosis and monitoring instruments
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Blood sugar monitoring systems
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Invasive blood sugar monitoring systems, single–use sensors
Invasive blood sugar monitoring systems, single–use sensors
Z1204011585
132 devices
SIBIONICS GS1 Continuous Glucose Monitoring System
Shenzhen SiSensing Co., Ltd.
·
,
China
Class IIb
CE/MDR
Syai
Beijing Synapsor Artificial Intelligence Co., Ltd.
·
,
China
Class IIb
CE/MDR
Instinct Go Glucose Sensor
Abbott Diabetes Care Ltd
·
,
United Kingdom
Class IIb
CE/MDR
FreeStyle Libre 2 Flash Glucose Monitoring System
Open recall
Abbott Diabetes Care Ltd
·
,
United Kingdom
Class IIb
FDA 510(k)
×3
K193371
Active
Cleared 12 Jun 2020
CE/MDR
SIBIONICS GS3 Continuous Glucose Monitoring System
Shenzhen SiSensing Co., Ltd.
·
,
China
Class IIb
CE/MDR
Dexcom ONE Continuous Glucose Monitoring System
Dexcom
·
,
United States
Class IIb
CE/MDD
Instinct Go Glucose Sensor
Abbott Diabetes Care Ltd
·
,
United Kingdom
Class IIb
CE/MDR
SIBIONICS GS1 Continuous Glucose Monitoring System
Shenzhen SiSensing Co., Ltd.
·
,
China
Class IIb
CE/MDR
SIBIONICS GS1 Continuous Glucose Monitoring System
Shenzhen SiSensing Co., Ltd.
·
,
China
Class IIb
CE/MDR
Glunovo
Infinovo Medical Co., Ltd
·
,
China
Class IIa
CE/MDD
DiaExpert
Microtech Medical (Hangzhou) Co., Ltd.
·
,
China
Class IIb
CE/MDR
DiaExpert
Microtech Medical (Hangzhou) Co., Ltd.
·
,
China
Class IIb
CE/MDR
SIBIONICS GS3 Continuous Glucose Monitoring System
Shenzhen SiSensing Co., Ltd.
·
,
China
Class IIb
CE/MDR
Instinct Glucose Sensor
Abbott Diabetes Care Ltd
·
,
United Kingdom
Class IIb
CE/MDR
Sol-Millennium CGM WEARABLE SENSOR
Zhejiang POCTech CO., Ltd.
·
,
China
Class IIb
CE/MDR
Syai
Beijing Synapsor Artificial Intelligence Co., Ltd.
·
,
China
Class IIb
CE/MDR
Sensors of Continuous Glucose Monitoring Systems
Zhejiang POCTech CO., Ltd.
·
,
China
Class IIb
CE/MDR
SIBIONICS GS3 Continuous Glucose Monitoring System
Shenzhen SiSensing Co., Ltd.
·
,
China
Class IIb
CE/MDR
Glucose Sensor
Medtrum Technologies Inc.
·
,
China
Class IIa
CE/MDD
SIBIONICS GS1 Continuous Glucose Monitoring System
Shenzhen SiSensing Co., Ltd.
·
,
China
Class IIb
CE/MDR
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