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Reusable Patient Monitoring ECG Cable

Class IMDR 2017/745On the market

Manufacturer: METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000022486
UDI-DI: 08698870309389
Basic UDI-DI: 86988703FMTECGCABLEE2XXVV
Reference: E200-4003/GI
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:49

Manufacturer products View details

Reusable Diagnostic EKG Cable

Class IMDR 2017/745On the market

Manufacturer: METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000022486
UDI-DI: 08698870309181
Basic UDI-DI: 86988703FMTEKGCABLEE1XX5K
Reference: E100/LNB/I
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 18:49

Manufacturer products View details

08594214060025

VDI ECG Cables and Leadwires – reusable

Class IMDR 2017/745On the marketDirect marking

Manufacturer: VDI Technologies s.r.o.
Manufacturer SRN: CZ-MF-000029098
UDI-DI: 08594214060025
Basic UDI-DI: 859421406CLWPU
Reference: N/A
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:51

Manufacturer products View details

08594214060018

VDI UHF-ECG

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: VDI Technologies s.r.o.
Manufacturer SRN: CZ-MF-000029098
UDI-DI: 08594214060018
Basic UDI-DI: 859421406UHFECGLP
Reference: VDISYS001
EMDN: Z12050302
EMDN description: ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:51

Manufacturer products View details

CardioHis app

CardioHis app V2.0

Class IIaMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: CARDIOHIS, S.L.
Manufacturer SRN: ES-MF-000046210
UDI-DI: 08437026132019
Basic UDI-DI: 843702613202C6
Reference: CHIS_001_B.1_Instructions for Use
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:16

Manufacturer products View details

08437026132002

CardioHis, 01

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: CARDIOHIS, S.L.
Manufacturer SRN: ES-MF-000046210
UDI-DI: 08437026132002
Basic UDI-DI: 8437026132001ZF
Reference: CHIS_001_B.1_Instructions for Use
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:16

Manufacturer products View details

MEDICALCSE

ECG-EXPERT

Class IIaMDR 2017/745On the marketActive deviceMeasuring functionSingle use

Manufacturer: CUSTOM SOFTWARE & ELECTRONICS, S.L
Manufacturer SRN: ES-MF-000003031
UDI-DI: 08437017782018
Basic UDI-DI: 8437017782018ECGEXPERTDP
Reference: ECG-EXPERT
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:06

Manufacturer products View details

MUSE NX

Class IIaMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278458070
Basic UDI-DI: 8406821BUG00305H5
Reference: 4101010-002
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EK12

Starting from V2

Class IIaMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278457547
Basic UDI-DI: 8406821BUG00415HD
Reference: 2104498-003
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

KISS+

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278441874
Basic UDI-DI: 8406821BUG00292HM
Reference: 2093551-100
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

MAC 5 A4 Resting ECG Analysis System

MAC 5 A4

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278276070
Basic UDI-DI: 8406821BUG00244HA
Reference: 8855001-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

MAC 7

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682144322
Basic UDI-DI: 8406821BUG00013GM
Reference: 2109091-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:47

Manufacturer products Authorised representative products Authorised representative actors View details

MAC 600

Class IIaMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682134859
Basic UDI-DI: 8406821BUG00169HM
Reference: 2042216-003
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

ECG LEADWIRE SET

CS ONE ECG Cable and Leadwires

Class IMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00840682125710
Basic UDI-DI: 8406821BUG00121GR
Reference: 2066468-005
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:46

Manufacturer products Authorised representative products Authorised representative actors View details

MAC VU360 V3.00 SW UPGRADE

MAC VU360 and CAM Connect 14

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00198953107263
Basic UDI-DI: 8406821BUG00094HF
Reference: 2030361-023
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

00195278421449

CAM-14

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278421449
Basic UDI-DI: 8406821BUG00183HF
Reference: 900995-102
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

CASE

CASE V7.0

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278403643
Basic UDI-DI: 8406821BUG00170H6
Reference: 2035123-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiosoft

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278364661
Basic UDI-DI: 8406821BUG00157HE
Reference: 2032557-001, 2032558-001, 2032559-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Cardionica

MIR066

Class IIaMDR 2017/745On the marketActive device

Manufacturer: MIR - Medical International Research S.p.A.
Manufacturer SRN: IT-MF-000014026
UDI-DI: 08052990321766
Basic UDI-DI: 805299032066E4
Reference: 91200000 - 91200001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 09:40

Manufacturer products View details

Clamp electrode

ECG Accessories

Class IMDR 2017/745On the market

Manufacturer: EF Medica Srl
Manufacturer SRN: IT-MF-000009938
UDI-DI: 08033049640953
Basic UDI-DI: 803304964EFACCECGG8
Reference: 60.100.02
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 07:59

Manufacturer products View details