SIGKNOW EZYPRO ECG Patch UG03-P3S

by Sigknow Biomedical Co., Ltd. 2 variants

Ref UG03-P3SModel UG02-P, UG02-PL, UG03-P1, UG03-P3S, UG03-P3C

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number0471987501PATCH6G Basic UDI-DI 04719875011108UDI-DI	Date5 Nov 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: SIGKNOW EZYPRO ECG Patch
Model / Reference: UG02-P, UG02-PL, UG03-P1, UG03-P3S, UG03-P3C

Primary DI / UDI-DI: 04719875011108
Basic UDI-DI: 0471987501PATCH6G
EMDN Code: C020501 ECG electrodes

Device Class: Class I
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: TW-MF-000026397
Authorised representative: MDSS GmbH DE-AR-000005430

Other devices from Sigknow Biomedical Co., Ltd.

EZYPRO ECG Recorder UG02

Class II
SIGKNOW EZYPRO ECG Patch UG02-P

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

Class IIa
SIGKNOW EZYPRO ECG Patch UG03-P3S

Class I
EZYPRO ECG Recorder (Model UG02)

Class II
EZYPRO ECG Recorder

Class IIa

See all devices from Sigknow Biomedical Co., Ltd. →

Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No