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53 device results listed.

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Awario Application

Class IIaMDDOn the marketActive device

Manufacturer: Heart2Save Oy
Manufacturer SRN: FI-MF-000004794
UDI-DI: 06429810583017
Basic UDI-DI: B-06429810583017
Reference: 2010
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

Awario Analysis Service

Class IIaMDDOn the marketActive device

Manufacturer: Heart2Save Oy
Manufacturer SRN: FI-MF-000004794
UDI-DI: 06429810583000
Basic UDI-DI: B-06429810583000
Reference: 1010
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

ISTEL ECG

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: DIAGNOSIS S.A.
Manufacturer SRN: PL-MF-000014187
UDI-DI: 05907581250693
Basic UDI-DI: B-05907581250693
Reference: 8004
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:18

Manufacturer products View details

Withings ECG Monitor 2

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Withings
Manufacturer SRN: FR-MF-000009505
UDI-DI: 03700546711442
Basic UDI-DI: 3700546711442UM
Reference: ECGSW2
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 02.08.2026 16:38

Manufacturer products View details

SATROECG

SATROECG v 1.1.

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: SATROECG SA
Manufacturer SRN: PL-MF-000044847
UDI-DI: 05903968149246
Basic UDI-DI: 5906660545SATROECG11VP
Reference: SATROECGV11
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:15

Manufacturer products View details

CardioNotes

Oprogramowanie do analizy EKG metodą Holtera

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: SynexCare sp. z o.o.
Manufacturer SRN: PL-MF-000038028
UDI-DI: 05905471789025
Basic UDI-DI: 590547178902003QL
Reference: 20031000
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:06

Manufacturer products View details

Cortrium Apex

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Cortrium ApS
Manufacturer SRN: DK-MF-000007827
UDI-DI: 05745000379033
Basic UDI-DI: 5745000379ECG-SoftwareZ4
Reference: Cortrium Apex
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:39

Manufacturer products View details

CardioCare@Home Pro

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Byteflies NV
Manufacturer SRN: BE-MF-000014680
UDI-DI: 05430001718195
Basic UDI-DI: 5430001718BF10000451K8
Reference: CardioCare@Home Pro
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:08

Manufacturer products View details

Google ECG app

GA13098

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Fitbit LLC
Manufacturer SRN: US-MF-000007439
UDI-DI: 00810028737815
Basic UDI-DI: 081003885FB603R8
Reference: GA13098
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

08800045800410

VN-C-18G

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: VUNO Inc.
Manufacturer SRN: KR-MF-000022266
UDI-DI: 08800045800410
Basic UDI-DI: 88000458DUVXY
Reference: VN-C-18G
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 22.07.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

Cortrium Apex

Class IIaMDDOn the marketActive device

Manufacturer: Cortrium ApS
Manufacturer SRN: DK-MF-000007827
UDI-DI: D-50002_a3A
Basic UDI-DI: B-50002_a3A
Reference: 50002_a
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:15

Manufacturer products View details

Garmin ECG App

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Garmin International, Inc.
Manufacturer SRN: US-MF-000037975
UDI-DI: 00860009117709
Basic UDI-DI: 0860009117709SS
Reference: Smartphone ECG App Component
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

CareIntellect MUSE

Class IIaMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00198953041741
Basic UDI-DI: 08406821BUG005807H
Reference: 5970545-001
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

Loss of Pulse Detection

FB612

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Fitbit LLC
Manufacturer SRN: US-MF-000007439
UDI-DI: 00810073612334
Basic UDI-DI: 081007361FB612NG
Reference: FB612
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

KardiaStation 12L (iOS)

KardiaStation 12L App

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: AliveCor, Inc.
Manufacturer SRN: US-MF-000029146
UDI-DI: B2100020190
Basic UDI-DI: ++B210KS12LS7
Reference: 002019
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 15.07.2026 14:53

Manufacturer products Authorised representative products Authorised representative actors View details

iSEKS Ecg

Class IIaMDDOn the marketActive device

Manufacturer: iSEKS diagnostics GmbH
Manufacturer SRN: DE-MF-000016478
UDI-DI: D-iSEKS-EcgEH
Basic UDI-DI: B-iSEKS-EcgEH
Reference: 01.P.30.00
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:19

Manufacturer products View details

D-CardiacNavigator6U

Cardiac Navigator

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: D-CardiacNavigator6U
Basic UDI-DI: B-CardiacNavigator6U
Reference: 9404256
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 14:14

Manufacturer products View details

06971049341987

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049341987
Basic UDI-DI: B-06971049341987
Reference: S
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

06971049341390

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Carewell EIectronics Co., Ltd.
Manufacturer SRN: CN-MF-000026800
UDI-DI: 06971049341390
Basic UDI-DI: B-06971049341390
Reference: S
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 06.07.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG Buddy

ECG Buddy-01

Class IIaMDR 2017/745On the marketActive device

Manufacturer: ARPI Inc.
Manufacturer SRN: KR-MF-000044471
UDI-DI: 08809877250035
Basic UDI-DI: 880987725ECGBUDDYFL
Reference: ECG Buddy-01
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details