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ZONCARE

iMAC 1800，iMAC 1800pro

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Wuhan Zoncare Bio-medical Electronics Co.,Ltd
Manufacturer SRN: CN-MF-000010439
UDI-DI: 06956913482171
Basic UDI-DI: B-06956913482171
Reference: /
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Italy
Authorised representative: Wellkang Ltd
Last updated: 03.08.2026 23:27

Manufacturer products Authorised representative products Authorised representative actors View details

μCor Heart Failure and Arrhythmia Management System (HFAMS)

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking

Manufacturer: ZOLL Manufacturing Corporation
Manufacturer SRN: US-MF-000027987
UDI-DI: 00855778005609
Basic UDI-DI: 0855778005K172510WG
Reference: 10A1073
EMDN: Z12050801
EMDN description: COMPLETE CARDIAC TELEMETRY SYSTEMS
First on market country: -
Authorised representative: ZOLL International Holding B.V.
Last updated: 03.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

μCor Heart Failure and Arrhythmia Management System (HFAMS)

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking

Manufacturer: ZOLL Manufacturing Corporation
Manufacturer SRN: US-MF-000027987
UDI-DI: 00855778005616
Basic UDI-DI: 0855778005K172510WG
Reference: 10A1067
EMDN: Z12050801
EMDN description: COMPLETE CARDIAC TELEMETRY SYSTEMS
First on market country: -
Authorised representative: ZOLL International Holding B.V.
Last updated: 03.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Electrocardiograph

H12

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429020823
Basic UDI-DI: B-06945429020823
Reference: H12
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Belgium
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Electrocardiograph

BeneHeart R12

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904042077
Basic UDI-DI: B-06944904042077
Reference: 123
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 19:54

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myLUX™

Class IIIMDR 2017/745On the marketActive device

Manufacturer: Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation
Manufacturer SRN: US-MF-000010993
UDI-DI: 00802526618208
Basic UDI-DI: 01915060000000000000220MG
Reference: 2929
EMDN: Z12050782
EMDN description: INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - SOFTWARE ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): 92887376 · Rev. C
Authorised representative: Guidant Europe NV/SA; Boston Scientific
Last updated: 03.08.2026 12:21

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myLUX™

Class IIIMDR 2017/745On the marketActive device

Manufacturer: Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation
Manufacturer SRN: US-MF-000010993
UDI-DI: 00802526618215
Basic UDI-DI: 01915060000000000000220MG
Reference: 2939
EMDN: Z12050782
EMDN description: INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - SOFTWARE ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): 92887376 · Rev. C
Authorised representative: Guidant Europe NV/SA; Boston Scientific
Last updated: 03.08.2026 12:21

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06922649906014

ECG1212

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Beijing M&B Electronic Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000010160
UDI-DI: 06922649906014
Basic UDI-DI: B-06922649906014
Reference: /
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Türkiye
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 06:00

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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

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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

EC-3H/ABP

EC-3H/ABP System

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.
Manufacturer SRN: HU-MF-000002846
UDI-DI: 05999883490532
Basic UDI-DI: B-05999883490532
Reference: SYS-3HABP-05
EMDN: Z12050402
EMDN description: MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)
First on market country: Hungary
Authorised representative: -
Last updated: 03.08.2026 03:25

Manufacturer products View details

Cardiax PC ECG USB

USB

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: IMED Orvosi Berendezéseket Fejlesztő Kft.
Manufacturer SRN: HU-MF-000015964
UDI-DI: 05999862292010
Basic UDI-DI: B-05999862292010
Reference: CRX02
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Hungary
Authorised representative: -
Last updated: 03.08.2026 03:25

Manufacturer products View details

ISTEL HR-2000

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: DIAGNOSIS S.A.
Manufacturer SRN: PL-MF-000014187
UDI-DI: 05907581254479
Basic UDI-DI: B-05907581254479
Reference: 8003
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:18

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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

M-TRACE mini

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: M4Medical Sp. z o.o.
Manufacturer SRN: PL-MF-000022164
UDI-DI: 05905358809020
Basic UDI-DI: B-05905358809020
Reference: M-TRACE mini
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 00:30

Manufacturer products View details

M-TRACE PC

M_TRACE PC

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: M4Medical Sp. z o.o.
Manufacturer SRN: PL-MF-000022164
UDI-DI: 05905358809013
Basic UDI-DI: B-05905358809013
Reference: M-TARCE PC
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 00:29

Manufacturer products View details

M-TRACE

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: M4Medical Sp. z o.o.
Manufacturer SRN: PL-MF-000022164
UDI-DI: 05905358809006
Basic UDI-DI: B-05905358809006
Reference: M-TRACE
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 00:29

Manufacturer products View details

PiCSO Impulse Console

1.01.4000

Class IIbMDDOn the market

Manufacturer: Miracor Medical SA
Manufacturer SRN: BE-MF-000001089
UDI-DI: 05430002982007
Basic UDI-DI: B-05430002982007
Reference: 1.01.4000
EMDN: Z12059099
EMDN description: VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHER
First on market country: France
Authorised representative: -
Last updated: 02.08.2026 21:51

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

Withings ECG App Display

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Withings
Manufacturer SRN: FR-MF-000009505
UDI-DI: 03700546711459
Basic UDI-DI: 3700546711459V6
Reference: ECG-APP-DSP
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 02.08.2026 16:38

Manufacturer products View details