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Disposable ECG Lead Wire

Disposable ECG Lead Wires

Class IMDR 2017/745On the marketSingle use

Manufacturer: Unimed Medical Supplies, Inc
Manufacturer SRN: CN-MF-000001480
UDI-DI: 06936735460441
Basic UDI-DI: 69456648DEC1VD
Reference: CDM5-310DS-I
EMDN: Z12050385
EMDN description: ELECTROCARDIOGRAPHS - CONSUMABLES
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

Limb Clamp Electrode

EKG accessories

Class IMDR 2017/745On the market

Manufacturer: Unimed Medical Supplies, Inc
Manufacturer SRN: CN-MF-000001480
UDI-DI: 06936735460052
Basic UDI-DI: 69456648REA1Y9
Reference: UU-LC-AA
EMDN: Z12050385
EMDN description: ELECTROCARDIOGRAPHS - CONSUMABLES
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:07

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ECG Monitor Lead Wire

ECG Cables & Lead Wires

Class IMDR 2017/745On the market

Manufacturer: Unimed Medical Supplies, Inc
Manufacturer SRN: CN-MF-000001480
UDI-DI: 06936735437078
Basic UDI-DI: 69456648REC1YF
Reference: MQB5-90/120P-I
EMDN: Z12050385
EMDN description: ELECTROCARDIOGRAPHS - CONSUMABLES
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

Portable ECG Monitor

PM10

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040104421
Basic UDI-DI: 69450401PM10NX
Reference: PM10
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Poland
Authorised representative: Prolinx GmbH
Last updated: 31.07.2026 20:03

Manufacturer products Authorised representative products Authorised representative actors View details

ECG Workstation

CONTEC8000G

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040103455
Basic UDI-DI: 69450401CONTEC8000GA5
Reference: CONTEC8000G
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Poland
Authorised representative: Prolinx GmbH
Last updated: 31.07.2026 20:03

Manufacturer products Authorised representative products Authorised representative actors View details

Dynamic ECG Systems

TLC5000, TLC6000

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040100294
Basic UDI-DI: 69450401TLC6000GX
Reference: TLC5000
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Poland
Authorised representative: Prolinx GmbH
Last updated: 31.07.2026 20:02

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Electrocardiograph

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040100089
Basic UDI-DI: 69450401ECG1212G5V
Reference: ECG300G
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: Prolinx GmbH
Last updated: 31.07.2026 20:02

Manufacturer products Authorised representative products Authorised representative actors View details

Electrocardiograph

BeneHeart R12/BeneHeart R12B/BeneHeart R12A/BeneHeart R3/BeneHeart R3B/BeneHeart R3A

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904040189
Basic UDI-DI: 69449040AB010000563R
Reference: BeneHeart R3
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

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Electrocardiograph

BeneHeart R900\BeneHeart R90\BeneHeart R700\BeneHeart R70\BeneHeart R300\BeneHeart R30

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053074919
Basic UDI-DI: 69449040AB010000573T
Reference: BeneHeart R70
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:51

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IEC 2-electrode 1-CH patient cable 125 mm

ECG Patient Cable

Class IMDR 2017/745On the market

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035221035
Basic UDI-DI: 643003522PatientCableF5
Reference: S0000022709
EMDN: Z12050480
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

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Bittium MedicalSuite Mobile

MedicalSuite Mobile v3.x

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035221011
Basic UDI-DI: 643003522SuiteMYW
Reference: 9530433
EMDN: Z12050482
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

Manufacturer products View details

Mini UL

Bittium MINI UL

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035220885
Basic UDI-DI: 643003522Cardiac3Z
Reference: S0000018246
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

Manufacturer products View details

Movesense Chest Strap MD - Size S

Movesense Chest Strap MD

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Movesense Ltd
Manufacturer SRN: FI-MF-000024281
UDI-DI: 06429810883025
Basic UDI-DI: 64298108830026M
Reference: MS2
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:45

Manufacturer products View details

SAADAT

Jam H1

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Pooyandegan rah saadat
Manufacturer SRN: IR-MF-000007104
UDI-DI: 06261388700799
Basic UDI-DI: 62613887JamH1WM
Reference: 57109489
EMDN: Z12050801
EMDN description: COMPLETE CARDIAC TELEMETRY SYSTEMS
First on market country: Sweden
Authorised representative: Trionara Technologies AB
Last updated: 31.07.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

SAADAT

JAM S3

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Pooyandegan rah saadat
Manufacturer SRN: IR-MF-000007104
UDI-DI: 06261388700560
Basic UDI-DI: 62613887JamS3XS
Reference: 26411662
EMDN: Z12050801
EMDN description: COMPLETE CARDIAC TELEMETRY SYSTEMS
First on market country: Sweden
Authorised representative: Trionara Technologies AB
Last updated: 31.07.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

SAADAT

Dena 1210

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Pooyandegan rah saadat
Manufacturer SRN: IR-MF-000007104
UDI-DI: 06261388700539
Basic UDI-DI: 62613887Dena1210MP
Reference: 99113285
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Sweden
Authorised representative: Trionara Technologies AB
Last updated: 31.07.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

SAADAT

Dena 650

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Pooyandegan rah saadat
Manufacturer SRN: IR-MF-000007104
UDI-DI: 06261388700379
Basic UDI-DI: 62613887Dena650BL
Reference: 70085480
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Sweden
Authorised representative: Trionara Technologies AB
Last updated: 31.07.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

EC-12R V6

EC-12S V6

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.
Manufacturer SRN: HU-MF-000002846
UDI-DI: 05999883490242
Basic UDI-DI: 5999883490ECGSRY
Reference: EC-12R V6
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:47

Manufacturer products View details

EC-2H Recorder

EC-2H System

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.
Manufacturer SRN: HU-MF-000002846
UDI-DI: 05999883490006
Basic UDI-DI: 5999883490HOLTERSR9
Reference: EC-2H Recorder
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:47

Manufacturer products View details

CARDIAX PC ECG WiFi/USB

CARDIAX PC Based ECG

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: IMED Orvosi Berendezéseket Fejlesztő Kft.
Manufacturer SRN: HU-MF-000015964
UDI-DI: 05999862292003
Basic UDI-DI: 5999862292CRXPCECG5Y
Reference: CRX01
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:45

Manufacturer products View details