Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
Medical equipment and related accessories, software and consumables
/
Instruments for functional explorations and therapeutic interventions
/
Cardiology and cardiosurgery instruments
/
Electrocardiographs
/
Electrocardiographs - medical device software
Electrocardiographs - medical device software
Z12050392
48 devices
Devices
Padsy Ecg
Medset Medizintechnik GmbH
·
,
DE
Class IIa
CE/MDD
Padsy Ecg
Medset Medizintechnik GmbH
·
,
DE
Class IIa
CE/MDD
Istel Ecg
Diagnosis S.A.
·
,
PL
Class IIa
CE/MDD
CareIntellect MUSE
Ge Medical Systems Information Technologies, Inc.
·
,
US
Class IIa
CE/MDR
SRA Pro
apoplex medical technologies GmbH
·
,
DE
Class IIa
CE/MDR
CardioCare@Home Pro
Byteflies NV
·
,
BE
Class I
CE/MDR
PMcardio® Core AI ECG Model
POWERFUL MEDICAL s.r.o.
·
,
SK
Class IIb
CE/MDR
iSEKS Ecg
iSEKS diagnostics GmbH
·
,
DE
Class IIa
CE/MDD
KardiaStation 12L (iOS)
AliveCor
·
,
US
Class IIb
CE/MDR
CardioNotes
SynexCare sp. z o.o.
·
,
PL
Class IIb
CE/MDR
TNP/MDR/0041/5915/2025
Active
Valid to Sep 2028
Zenicor View
Zenicor Medical Systems AB
·
,
SE
Class IIa
CE/MDR
Awario Application
Heart2Save Oy
·
,
FI
Class IIa
CE/MDD
Muse Nx
Ge Medical Systems Information Technologies, Inc.
·
,
US
Class IIa
CE/MDR
GUDID
on market
PMcardio® OMI AI ECG Model
POWERFUL MEDICAL s.r.o.
·
,
SK
Class IIb
CE/MDR
Loss of Pulse Detection
Fitbit LLC
·
,
US
Class IIa
FDA 510(k)
K242967
Active
Cleared 25 Feb 2025
CE/MDR
Padsy Ecg 4.6
Medset Medizintechnik GmbH
·
,
DE
Class IIa
CE/MDR
44911221064
Active
Valid to Jul 2029
PMcardio
POWERFUL MEDICAL s.r.o.
·
,
SK
Class IIb
CE/MDR
Holter Analysis Software
Wuhan United Imaging Surgical Co., Ltd.
·
,
CN
Class IIa
CE/MDR
ECG app
Xiaomi Communications Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Cardiac Navigator
Bittium Biosignals, Ltd.
·
,
FI
Class IIa
CE/MDD
Previous
Next