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EZYPRO Wearable ECG System – EZYPRO ECG Recorder, SIGKNOW ECG Patch, accessories, supporting software, and EZYPRO Analyzer

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Class IIaNot specifiedOn the marketSingle use

Manufacturer: Sigknow Biomedical Co., Ltd.
Manufacturer SRN: TW-MF-000026397
UDI-DI: 04719875010484
Basic UDI-DI: B-04719875010484
Reference: UG02
EMDN: C020599
EMDN description: CARDIAC DIAGNOSTIC DEVICES - OTHER
First on market country: Czechia
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

SIGKNOW EZYPRO ECG Patch UG02-PL

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Class INot specifiedOn the marketSingle use

Manufacturer: Sigknow Biomedical Co., Ltd.
Manufacturer SRN: TW-MF-000026397
UDI-DI: 04719875011054
Basic UDI-DI: 0471987501PATCH6G
Reference: UG02-PL
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Greece
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 09:50

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SIGKNOW EZYPRO ECG Patch UG03-P1

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Class INot specifiedOn the marketSingle use

Manufacturer: Sigknow Biomedical Co., Ltd.
Manufacturer SRN: TW-MF-000026397
UDI-DI: 04719875011061
Basic UDI-DI: 0471987501PATCH6G
Reference: UG03-P1
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

SIGKNOW EZYPRO ECG Patch UG03-P3S

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Class INot specifiedOn the marketSingle use

Manufacturer: Sigknow Biomedical Co., Ltd.
Manufacturer SRN: TW-MF-000026397
UDI-DI: 04719875011078
Basic UDI-DI: 0471987501PATCH6G
Reference: UG03-P3S
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

SIGKNOW EZYPRO ECG Patch UG03-P3C

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Class INot specifiedOn the marketSingle use

Manufacturer: Sigknow Biomedical Co., Ltd.
Manufacturer SRN: TW-MF-000026397
UDI-DI: 04719875011085
Basic UDI-DI: 0471987501PATCH6G
Reference: UG03-P3C
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

SIGKNOW EZYPRO ECG Patch UG03-P1

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Class INot specifiedOn the marketSingle use

Manufacturer: Sigknow Biomedical Co., Ltd.
Manufacturer SRN: TW-MF-000026397
UDI-DI: 04719875011092
Basic UDI-DI: 0471987501PATCH6G
Reference: UG03-P1
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

SIGKNOW EZYPRO ECG Patch UG03-P3S

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Class INot specifiedOn the marketSingle use

Manufacturer: Sigknow Biomedical Co., Ltd.
Manufacturer SRN: TW-MF-000026397
UDI-DI: 04719875011108
Basic UDI-DI: 0471987501PATCH6G
Reference: UG03-P3S
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

SIGKNOW EZYPRO ECG Patch UG03-P3C

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Class INot specifiedOn the marketSingle use

Manufacturer: Sigknow Biomedical Co., Ltd.
Manufacturer SRN: TW-MF-000026397
UDI-DI: 04719875011115
Basic UDI-DI: 0471987501PATCH6G
Reference: UG03-P3C
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Connection cables

Electrodes for Neurodiagnostic and accessories

Class IMDR 2017/745On the market

Manufacturer: Spes Medica S.p.A.
Manufacturer SRN: IT-MF-000008858
UDI-DI: 18054655026372
Basic UDI-DI: 8054655000013XX
Reference: LEAD0626331
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:32

Manufacturer products View details

Electro-gel

Class IMDR 2017/745On the marketSingle use

Manufacturer: Telic, S.A.U.
Manufacturer SRN: ES-MF-000001853
UDI-DI: 03760316090092
Basic UDI-DI: 8427734ECGGELVB
Reference: PF0106
EMDN: C020599
EMDN description: CARDIAC DIAGNOSTIC DEVICES - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:28

Manufacturer products View details

Disposable ECG electrodes with connection cable

Class IMDR 2017/745On the marketSingle use

Manufacturer: FIAB S.p.A.
Manufacturer SRN: IT-MF-000005988
UDI-DI: 18058480753649
Basic UDI-DI: 803300326608000006SM
Reference: E347
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:25

Manufacturer products View details

Connection cables

Electrodes for Neurodiagnostic and accessories

Class IMDR 2017/745On the market

Manufacturer: Spes Medica S.p.A.
Manufacturer SRN: IT-MF-000008858
UDI-DI: 18054655025641
Basic UDI-DI: 8054655000013XX
Reference: LEAD1526331
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:24

Manufacturer products View details

EKA-AS-A

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Shenzhen Caremed Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010579
UDI-DI: 06931973429229
Basic UDI-DI: 69707585REE87
Reference: EKA-AS-A
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

EK10U-NK2-BI

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Shenzhen Caremed Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010579
UDI-DI: 06931973408446
Basic UDI-DI: 69707585ECG01QK
Reference: EK10U-NK2-BI
EMDN: C020599
EMDN description: CARDIAC DIAGNOSTIC DEVICES - OTHER
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable ECG Electrodes

Class IMDR 2017/745On the marketActive deviceSingle use

Manufacturer: Shanghai Intco Electrode Manufacturing Co., Ltd.
Manufacturer SRN: CN-MF-000053403
UDI-DI: 16970020054189
Basic UDI-DI: 697002005-0-ECG-9A
Reference: SF08
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details

Specifications HT-XD-F01、HT-XD-F02、HT-XD-F03、HT-XD-F04、HT-XD-F05、HT-XD-F06、HT-XD-F07、HT-XD-F08、HT-XD-F09、HT-XD-F10、HT-XD-F11、HT-XD-F12、HT-XD-F13、HT-XD-F14、HT-XD-F15、HT-XD-F16、etc

Class IMDR 2017/745On the marketSingle use

Manufacturer: Zhejiang Jinhua Huatong Medical Appliance Co., Ltd
Manufacturer SRN: CN-MF-000010166
UDI-DI: 06944301303009
Basic UDI-DI: 69443013HT01NA
Reference: HT-XD-F01
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:41

Manufacturer products Authorised representative products Authorised representative actors View details

Fast-Fix Electrode

Fast-Fix Electrodes

Class IMDR 2017/745On the marketSingle use

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035221110
Basic UDI-DI: 643003522Fast-FixL8
Reference: 901155
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

Manufacturer products View details

OmegaSnap 1-CH ECG Electrode

OmegaSnap

Class IMDR 2017/745On the marketSingle use

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035220519
Basic UDI-DI: 643003522ECGElectrodeTY
Reference: 9404644
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

Manufacturer products View details

Awario Gem Silver/Black

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Heart2Save Oy
Manufacturer SRN: FI-MF-000004794
UDI-DI: 06429810583055
Basic UDI-DI: 64298105834010UN
Reference: 4010
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:40

Manufacturer products View details

Awario Care White

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Heart2Save Oy
Manufacturer SRN: FI-MF-000004794
UDI-DI: 06429810583031
Basic UDI-DI: 64298105833010UF
Reference: 3010
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:40

Manufacturer products View details