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Medical equipment and related accessories, software and consumables
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Blood sugar monitoring systems
Blood sugar monitoring systems
Z12040115
264 devices
Subcategories
4
Z1204011501
Non invasive blood sugar monitoring systems
27
devices
Z1204011502
Invasive blood sugar monitoring systems
51
devices
Z1204011585
Invasive blood sugar monitoring systems, single–use sensors
132
devices
Z1204011599
Blood sugar monitoring systems - other
54
devices
Devices
Dexcom ONE Continuous Glucose Monitoring System
Dexcom
·
,
United States
Class IIb
CE/MDD
SIBIONICS GS1 ECO Continuous Glucose Monitoring System - Sensor Applicator Kit
Shenzhen SiSensing Co., Ltd.
·
,
China
Class IIb
CE/MDR
Dexcom Flex CGM System
Dexcom
·
,
United States
Class IIb
CE/MDR
FreeStyle Libre 3 Plus Continuous Glucose Monitoring System
Abbott Diabetes Care Ltd
·
,
United Kingdom
Class IIb
CE/MDR
CareSens Air Continuous Glucose Monitoring System
i-SENS, Inc.
·
,
South Korea
Class IIb
CE/MDR
Pic CGM WEARABLE SENSOR
Zhejiang POCTech CO., Ltd.
·
,
China
Class IIb
CE/MDR
Glunovo
Infinovo Medical Co., Ltd
·
,
China
Class IIa
CE/MDD
SIBIONICS GS3 Continuous Glucose Monitoring System
Shenzhen SiSensing Co., Ltd.
·
,
China
Class IIb
CE/MDR
Pic CGM WEARABLE SENSOR
Zhejiang POCTech CO., Ltd.
·
,
China
Class IIb
CE/MDR
Instinct 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 GS3 Continuous Glucose Monitoring System
Shenzhen SiSensing Co., Ltd.
·
,
China
Class IIb
CE/MDR
Dexcom ONE+ CGM System
Dexcom
·
,
United States
Class IIb
CE/MDR
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
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