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Electrocardiographs - medical device software
Electrocardiographs - medical device software
Z12050392
48 devices
Satroecg
Satroecg SA
·
,
Poland
Class IIa
CE/MDR
TNP/MDR/0051/4464/2026
Active
Valid to Mar 2029
Pulse Wave arrhythmia analysis
Huawei Device Co., Ltd.
·
,
China
Class IIa
CE/MDR
OMRON Connect
OMRON Healthcare Co., Ltd.
·
,
Japan
Class IIa
CE/MDR
Garmin ECG App
Garmin International, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Withings ECG Monitor
Withings SA
·
,
France
Class IIa
CE/MDR
Cardiovit Cs-104
Schiller AG
·
,
Switzerland
Class IIa
CE/MDR
Google ECG app
Fitbit LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Awario Analysis Service
Heart2Save Oy
·
,
Finland
Class IIa
CE/MDD
ECG App
Huawei Device Co., Ltd.
·
,
China
Class IIb
CE/MDR
ECG Buddy
ARPI Inc.
·
,
South Korea
Class IIa
CE/MDR
EK12
Ge Medical Systems Information Technologies, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Cortrium Apex
Cortrium ApS
·
,
Denmark
Class IIa
CE/MDD
Garmin ECG App
Garmin International, Inc.
·
,
United States
Class IIa
FDA 510(k)
K221774
Active
Cleared 12 Jan 2023
CE/MDR
+1
authorizations
Cortrium Apex
Cortrium ApS
·
,
Denmark
Class IIa
CE/MDR
ECG Analyzer
Shenzhen OPPO Health Technology Corp., Ltd.
·
,
China
Class IIb
CE/MDR
KardiaStation 12L (Android)
AliveCor
·
,
United States
Class IIb
CE/MDR
Withings ECG Monitor 2
Withings SA
·
,
France
Class IIa
CE/MDR
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