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Vital Signs™ ECG Connector for CAM14 Mactrode™, V3R, Gray, AHA

Vital Signs™ Diagnostic Cardiology Connectors

Class IMDR 2017/745On the marketDirect marking

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10190752180086
Basic UDI-DI: 0190752TDHEL146PD
Reference: 406551-033
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 15.07.2026 23:00

Manufacturer products View details

Vital Signs™ Leadwire Set, ECG, Grabber 12-Lead, IEC, 74 cm/29 in

Vital Signs™ Diagnostic Cardiology Leadwires and Cables

Class IMDR 2017/745On the marketDirect marking

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10190752179974
Basic UDI-DI: 0190752TDHEL141P3
Reference: 38401808
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 15.07.2026 23:00

Manufacturer products View details

Multi-Link™ X2 ECG Reusable Trunk Cable 6-Lead for GE, AHA, 23 cm/ 9 in

Multi-Link™ X2 ECG Reusable Trunk Cable

Class IMDR 2017/745On the marketDirect marking

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10190752179721
Basic UDI-DI: 0190752TDHEL1313UT
Reference: 2090100-043
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

Multi-Link™ Single-Patient-Use ECG Leadwire Set 3-LEAD, SNAP, IEC, 100 cm/39 in

Multi-Link™ Single-Patient-Use ECG Leadwire Set

Class IMDR 2017/745On the marketSingle use

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10190752179394
Basic UDI-DI: 0190752TDHEL1311UP
Reference: 2052104-001
EMDN: Z12050385
EMDN description: ELECTROCARDIOGRAPHS - CONSUMABLES
First on market country: Finland
Authorised representative: -
Last updated: 15.07.2026 22:59

Manufacturer products View details

Vital Signs™ Cardiac Output Care Cable for GE Monitors, 3.6 m/12 ft

Vital Signs™ Cardiac Output Care Cable

Class IMDR 2017/745No longer on the marketDirect marking

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10190752179349
Basic UDI-DI: 0190752TDHEL1221UM
Reference: 2025248-001
EMDN: Z12050580
EMDN description: CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - 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, Dedicated Banana AHA, 66 cm/26 in, V3R

Vital Signs™ Individual replacement leadwires for banana-ended leadwires

Class IMDR 2017/745On the marketDirect marking

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10190752179202
Basic UDI-DI: 0190752TDHEL1412UW
Reference: 2020558-011
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

Multi-Link™ ECG Care Cable, 3/5-lead, AHA, 3.6 m/12 ft

Multi-Link™ ECG Care Cable

Class IMDR 2017/745On the marketDirect marking

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10190752179103
Basic UDI-DI: 0190752TDHEL136PA
Reference: 2017003-001
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™ 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

D-Heart

Class IIaMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: Strena Medical Srl Società Benefit
Manufacturer SRN: IT-MF-000021080
UDI-DI: +G243ECG000DHR200
Basic UDI-DI: ++G243DHEARTECG4L
Reference: ECG000-DHR20
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 20:21

Manufacturer products View details

CER-S

CER-S v. 4.y.z

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: CARDIO CALM S.R.L.
Manufacturer SRN: IT-MF-000017950
UDI-DI: B972CCZ12050482050
Basic UDI-DI: ++B972CERS437
Reference: CCZ1205048205
EMDN: Z12050482
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 17:23

Manufacturer products View details

TELECARDIOCALM

Class IIaMDR 2017/745On the market

Manufacturer: CARDIO CALM S.R.L.
Manufacturer SRN: IT-PR-000033759
UDI-DI: +B972CC01020B
Basic UDI-DI: ++B972TELECC32W
Reference: CC0102
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 17:18

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