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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

Checkme

ER2-S

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Viatom Technology Co., Ltd.
Manufacturer SRN: CN-MF-000012182
UDI-DI: 06934440101925
Basic UDI-DI: 69344401ER2-SHM
Reference: ER2-S
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

Electrocardiograph

E30

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Guangdong Biolight Meditech Co., Ltd
Manufacturer SRN: CN-MF-000006333
UDI-DI: 06932562300547
Basic UDI-DI: 69325623100274B
Reference: E30
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 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Electrocardiograph

E65

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Guangdong Biolight Meditech Co., Ltd
Manufacturer SRN: CN-MF-000006333
UDI-DI: 06932562300516
Basic UDI-DI: 693256231001544
Reference: E65
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 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

06932554417604

ECG-V1

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Xiaomi Communications Co., Ltd.
Manufacturer SRN: CN-MF-000046125
UDI-DI: 06932554417604
Basic UDI-DI: 69325544010101SR
Reference: ECG-V1
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: BioDomi GmbH
Last updated: 02.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

OPUS mini

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: String Polska Sp. z o.o.
Manufacturer SRN: PL-MF-000035907
UDI-DI: 59051084491488
Basic UDI-DI: 5905108449112CHECGOPUSMVK
Reference: 12CHECGOPUSM
EMDN: Z12050302
EMDN description: ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 06:06

Manufacturer products View details

OPUS1

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: String Polska Sp. z o.o.
Manufacturer SRN: PL-MF-000035907
UDI-DI: 59051084491174
Basic UDI-DI: 5905108449112CHECGOPUS1TV
Reference: 12CHECGOPUS1
EMDN: Z12050302
EMDN description: ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 06:06

Manufacturer products View details

kabel EKG do monitorowania

ECG monitoring cables

Class IMDR 2017/745On the market

Manufacturer: SORIMEX sp. z o.o.
Manufacturer SRN: PL-MF-000020958
UDI-DI: 05903002200148
Basic UDI-DI: 5903002221085L
Reference: KAX-3/4,7-Wb/L-270-31
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:29

Manufacturer products View details

przewód dołączeniowy

leadwires

Class IMDR 2017/745On the market

Manufacturer: SORIMEX sp. z o.o.
Manufacturer SRN: PL-MF-000020958
UDI-DI: 05903002200001
Basic UDI-DI: 59030022211057
Reference: PD-8-2a/L-90-31C
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:29

Manufacturer products View details

T1 SmarterSkin Sensor

T1S

Class IMDR 2017/745On the market

Manufacturer: Umana Medical Technologies Ltd
Manufacturer SRN: MT-MF-000018092
UDI-DI: 05350627900241
Basic UDI-DI: 53506279T1SMARTERSKIN37
Reference: T1S
EMDN: Z12050385
EMDN description: ELECTROCARDIOGRAPHS - CONSUMABLES
First on market country: Türkiye
Authorised representative: -
Last updated: 02.07.2026 03:13

Manufacturer products View details

ECG Harness

01-2001

Class IMDR 2017/745On the marketActive device

Manufacturer: Remote Diagnostic Technologies Ltd.
Manufacturer SRN: GB-MF-000002127
UDI-DI: 05060472440464
Basic UDI-DI: 506047244BM733VC
Reference: 01-2001 / 989706011050
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Luxembourg
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 02.07.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

3-Lead ECG CBL (IEC) 6ft

ECG Cables

Class IMDR 2017/745On the marketActive device

Manufacturer: Remote Diagnostic Technologies Ltd.
Manufacturer SRN: GB-MF-000002127
UDI-DI: 05060472440181
Basic UDI-DI: 506047244BM732VA
Reference: 01-2038/989706010280
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Norway
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 02.07.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

XOresearch Cardio.AI™

XOresearch Cardio.AI

Class IIaMDR 2017/745On the marketActive device

Manufacturer: XOresearch
Manufacturer SRN: LV-MF-000043795
UDI-DI: 04751047370019
Basic UDI-DI: 475104737CARDIOAIQE
Reference: XOresearch Cardio.AI
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Latvia
Authorised representative: -
Last updated: 02.07.2026 00:38

Manufacturer products View details

PMcardio® Core AI ECG Model

Class IIbMDR 2017/745On the marketActive device

Manufacturer: POWERFUL MEDICAL s.r.o.
Manufacturer SRN: SK-MF-000015799
UDI-DI: 04260738430135
Basic UDI-DI: 426073843PMcardio0003H6
Reference: Core AI ECG Model
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 23:07

Manufacturer products View details