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Vital Signs™ Cable for CAM14 for MAC5500™, 1.3 m/4.2 ft

Vital Signs™ Communication Cable

Class IMDR 2017/745On the marketDirect marking

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10190752179011
Basic UDI-DI: 0190752TDHEL1411UU
Reference: 2016560-001
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 15.07.2026 22:59

Manufacturer products View details

Vital Signs™ Diagnostic Cardiology Leadwire Set, Loose, 10/set, Banana, AHA

Vital Signs™ Banana-ended leadwires with replaceable leadwires

Class IMDR 2017/745On the marketDirect marking

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10190752178977
Basic UDI-DI: 0190752TDHEL145PB
Reference: 2016032-001
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 15.07.2026 22:59

Manufacturer products View details

Vital Signs™ Fetal Spiral Electrode Cable for Corometrics, round connector, 2.4 m

Vital Signs™ Fetal Spiral Electrode Cable

Class IMDR 2017/745On the marketDirect marking

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10190752178922
Basic UDI-DI: 0190752TDHEL071P7
Reference: 1590AAO
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 15.07.2026 22:59

Manufacturer products View details

Vital Signs™ Diagnostic Cardiology Adapter, KISS™ system to disposable electrode (snap/banana)

Vital Signs™ Diagnostic Cardiology Leadwire Adapter

Class IMDR 2017/745On the market

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10190752178878
Basic UDI-DI: 0190752TDHEL149PK
Reference: 30344421
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 15.07.2026 22:59

Manufacturer products View details

Vital Signs™ Leadwire A1 for KISS™ System

Vital Signs™ ECG leadwires for KISS system

Class IMDR 2017/745On the marketDirect marking

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10190752178670
Basic UDI-DI: 0190752TDHEL147PF
Reference: 2022862-006
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 15.07.2026 22:59

Manufacturer products View details

00190199649286

2.X

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Apple Inc.
Manufacturer SRN: US-MF-000013709
UDI-DI: 00190199649286
Basic UDI-DI: 0190199ECGApp2QP
Reference: ECG app 2.X
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Apple Distribution International Limited
Last updated: 15.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

00190198909534

1.X

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Apple Inc.
Manufacturer SRN: US-MF-000013709
UDI-DI: 00190198909534
Basic UDI-DI: 0190198ECGAppMY
Reference: ECG app 1.X
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Apple Distribution International Limited
Last updated: 15.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

CardioPad Lite

CPL-T1

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Aizoi s.r.l.
Manufacturer SRN: IT-MF-000026605
UDI-DI: G419CPLT10
Basic UDI-DI: ++G419CARDIOPAD9U
Reference: CPL-T1
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 21:04

Manufacturer products View details

Kardia 12L

AC-027

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: AliveCor, Inc.
Manufacturer SRN: US-MF-000029146
UDI-DI: B210AC0270
Basic UDI-DI: ++B210AC027HU
Reference: AC-027
EMDN: Z12050302
EMDN description: ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS
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

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

BTL Flexi 12 ECG

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BTL Industries Limited
Manufacturer SRN: GB-MF-000034894
UDI-DI: B108076POFF12MEU00
Basic UDI-DI: ++B108076POEUZF
Reference: C076.014; C076.013; C076.004; C076.003
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Northern Ireland
Authorised representative: BTL ITALIA S.r.l.
Last updated: 15.07.2026 14:50

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

Fitbit Irregular Rhythm Notifications

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Fitbit LLC
Manufacturer SRN: US-MF-000007439
UDI-DI: 00810038852720
Basic UDI-DI: 081003885FB604RA
Reference: FB604
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

HS80G-L1 12 channel ECG device

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság
Manufacturer SRN: HU-MF-000017747
UDI-DI: D-HS80G-L1BE
Basic UDI-DI: B-HS80G-L1BE
Reference: KHS80GL1
EMDN: Z12050302
EMDN description: ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS
First on market country: Hungary
Authorised representative: -
Last updated: 14.07.2026 00:57

Manufacturer products View details

HS112-C1 12 channel ECG device

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság
Manufacturer SRN: HU-MF-000017747
UDI-DI: D-HS112-C13P
Basic UDI-DI: B-HS112-C13P
Reference: KHS112C1
EMDN: Z12050302
EMDN description: ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS
First on market country: Hungary
Authorised representative: -
Last updated: 14.07.2026 00:57

Manufacturer products View details

WAM/AMXX Lead Set

Class IMDR 2017/745On the market

Manufacturer: Welch Allyn, Inc.
Manufacturer SRN: US-MF-000013394
UDI-DI: 00812345025705
Basic UDI-DI: 0732094GMN901006BNJ
Reference: 9293-047-71
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Welch Allyn Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

WAM/AMXX Lead Set

Class IMDR 2017/745On the market

Manufacturer: Welch Allyn, Inc.
Manufacturer SRN: US-MF-000013394
UDI-DI: 00812345025682
Basic UDI-DI: 0732094GMN901006BNJ
Reference: 9293-047-67
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Welch Allyn Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

WAM/AMXX Lead Set

Class IMDR 2017/745On the market

Manufacturer: Welch Allyn, Inc.
Manufacturer SRN: US-MF-000013394
UDI-DI: 00812345025668
Basic UDI-DI: 0732094GMN901006BNJ
Reference: 9293-047-65
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Welch Allyn Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

WAM/AMXX Lead Set

Class IMDR 2017/745On the market

Manufacturer: Welch Allyn, Inc.
Manufacturer SRN: US-MF-000013394
UDI-DI: 00812345021998
Basic UDI-DI: 0732094GMN901006BNJ
Reference: 9293-047-60
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Welch Allyn Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

WAM/AMXX Lead Set

Class IMDR 2017/745On the market

Manufacturer: Welch Allyn, Inc.
Manufacturer SRN: US-MF-000013394
UDI-DI: 00812345022766
Basic UDI-DI: 0732094GMN901006BNJ
Reference: 9293-047-70
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Welch Allyn Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details