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EC Sense

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Cardiolex Medical AB
Manufacturer SRN: SE-MF-000016895
UDI-DI: 07350117580005
Basic UDI-DI: 7350117580000000003YM
Reference: CN SE
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:59

Manufacturer products View details

Reusable EKG / ECG Leadwire

Class IMDR 2017/745On the market

Manufacturer: METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000022486
UDI-DI: 08698870333865
Basic UDI-DI: 86988703FMTEKGECGLEADR7
Reference: E105GI/10
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:33

Manufacturer products View details

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: 08698870373588
Basic UDI-DI: 86988703FMTECGCABLEE2XXVV
Reference: E200-5077/GI
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:33

Manufacturer products View details

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: 08698870371393
Basic UDI-DI: 86988703FMTECGCABLEE2XXVV
Reference: E200-3066/GI
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:33

Manufacturer products View details

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: 08698870362520
Basic UDI-DI: 86988703FMTECGCABLEE2XXVV
Reference: E200-5050/SI
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:33

Manufacturer products View details

06976589110017

ECG Analyzer-1

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shenzhen OPPO Health Technology Corp., Ltd.
Manufacturer SRN: CN-MF-000041322
UDI-DI: 06976589110017
Basic UDI-DI: 697658911ECGAnalyzer-15J
Reference: /
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: Share info GmbH
Last updated: 02.07.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

electrocardiograph

ECG 301

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Le Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000007686
UDI-DI: 06975070970031
Basic UDI-DI: 6975070970000AQ
Reference: 06975070970031
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Austria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

06974782941056

uMH E203

Class IMDR 2017/745On the marketActive deviceContains latex

Manufacturer: Wuhan United Imaging Surgical Co., Ltd.
Manufacturer SRN: CN-MF-000032693
UDI-DI: 06974782941056
Basic UDI-DI: 697478294leadwire001MQ
Reference: /
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

Holter Analysis Software

uMH WS300

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Wuhan United Imaging Surgical Co., Ltd.
Manufacturer SRN: CN-MF-000032693
UDI-DI: 06974782940936
Basic UDI-DI: 697478294software001FH
Reference: 88001269
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

Holter Recorder

uMH H200 Alpha、uMH H200 Beta

Class IIaMDR 2017/745No longer on the marketActive device

Manufacturer: Wuhan United Imaging Surgical Co., Ltd.
Manufacturer SRN: CN-MF-000032693
UDI-DI: 06974782940912
Basic UDI-DI: 697478294holter001PL
Reference: 88001255
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

06972820965019

ECG cables

Class IMDR 2017/745On the marketActive deviceMeasuring functionReusable

Manufacturer: Shenzhen SINO-K Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021157
UDI-DI: 06972820965019
Basic UDI-DI: 697282096SG3101PL4
Reference: ECG
EMDN: Z12050385
EMDN description: ELECTROCARDIOGRAPHS - CONSUMABLES
First on market country: Ireland
Authorised representative: Prolinx GmbH
Last updated: 02.07.2026 13:10

Manufacturer products Authorised representative products Authorised representative actors View details

ZONCARE

iMAC 12,iMAC 12pro,iMAC 120,iMAC 120pro,iMAC 300,iMAC 300pro，E120,E120s,E120pro,E12,E12s,E12pro,E30,E30s,E30pro

Class IIaMDR 2017/745On the marketActive deviceImplantable

Manufacturer: Wuhan Zoncare Bio-medical Electronics Co.,Ltd
Manufacturer SRN: CN-MF-000010439
UDI-DI: 06956913490046
Basic UDI-DI: 695691348214MQ
Reference: /
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

ZONCARE

iMAC 1800, iMAC 1800pro

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Wuhan Zoncare Bio-medical Electronics Co.,Ltd
Manufacturer SRN: CN-MF-000010439
UDI-DI: 06956913490039
Basic UDI-DI: 695691348217MW
Reference: /
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

Shenzhen Comen Medical Instruments Co., Ltd.

electrocardiograph

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Yuezhongxing Technology Co., Ltd
Manufacturer SRN: CN-MF-000024102
UDI-DI: 16945429012344
Basic UDI-DI: 694542901234HD
Reference: 001
EMDN: Z12050302
EMDN description: ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS
First on market country: Austria
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 10:48

Manufacturer products Authorised representative products Authorised representative actors View details

06941900606647

PC-80D、H600

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Creative Industry Co., Ltd.
Manufacturer SRN: CN-MF-000009430
UDI-DI: 06941900606647
Basic UDI-DI: 69419006PC80D01CV
Reference: PC-80D
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

06941900602502

PC-80B、CARDIO-B

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Creative Industry Co., Ltd.
Manufacturer SRN: CN-MF-000009430
UDI-DI: 06941900602502
Basic UDI-DI: 69419006PC80BS01JB
Reference: CARDIO-B
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

06941487275335

ECG-1

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Huawei Device Co., Ltd.
Manufacturer SRN: CN-MF-000022811
UDI-DI: 06941487275335
Basic UDI-DI: 69414872ECGApp9437497TK
Reference: 7533
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

Viatom

BP3F, BP3G, HDM3F, HDM3G

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Viatom Technology Co., Ltd.
Manufacturer SRN: CN-MF-000012182
UDI-DI: 06934440102649
Basic UDI-DI: 69344401BP3FNL
Reference: BP3F
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

Checkme

BP2，BP2B，BP2V，BP2W

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Viatom Technology Co., Ltd.
Manufacturer SRN: CN-MF-000012182
UDI-DI: 06934440101949
Basic UDI-DI: 69344401BP2XD
Reference: BP2V
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

Checkme

ER2-SC

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Viatom Technology Co., Ltd.
Manufacturer SRN: CN-MF-000012182
UDI-DI: 06934440101932
Basic UDI-DI: 69344401ER2-SCED
Reference: ER2-SC
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details