Home GUDID 04719875011023
EZYPRO ECG Recorder
Primary DI 04719875011023
Brand EZYPRO ECG Recorder
Company SIGKNOW BIOMEDICAL CO., LTD.
Model UG02
Device description EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac rhythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recording, the recorded ECG data can be transferred in an available file on PC via the USB connection. During wearing, EZYPRO ECG recorder (model: UG02) can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals. EZY iSee does not contain diagnostic interpretation. UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data. Content: (Accessories) ECG patch with a 14-day service ID, overlay tape, dust plug
Published 2026-06-01
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use true
Product Codes# Code, Name table Code Name DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14719875011020 Package GS1 10 In Commercial Distribution 24719875011027 Package GS1 5 In Commercial Distribution 04719875011023 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14719875011020 14719875011020 24719875011027 24719875011027 04719875011023 04719875011023 4719875011023
GMDN Terms# Term, Definition table Term Definition Ambulatory recorder conductive patch An adhesive patch intended to fix a patient-worn recorder (e.g., electrocardiographic long-term ambulatory recorder) to skin electrodes during long-term electrophysiological recording/monitoring [e.g., electrocardiogram (ECG)], and to transmit the electrical signals from the electrodes to the recorder. It is an electrical conducting patch made of metal and synthetic polymer materials. This is a single-use device.
Regulatory Flags# DUNS number 656154969 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04719875011016 EZYPRO ECG Recorder UG02 2026-06-01 04719875011030 EZYPRO ECG Recorder UG02 2026-06-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08720256776567 Corsano CardioWatch 287-2 System Corsano Health B.V. DRG 2026-06-02 04719875011016 EZYPRO ECG Recorder SIGKNOW BIOMEDICAL CO., LTD. DRG 2026-06-01 04719875011030 EZYPRO ECG Recorder SIGKNOW BIOMEDICAL CO., LTD. DRG 2026-06-01 B3944060056010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3944670047010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945000030010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945300046010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945300054010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945300054020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945600013020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048030 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048040 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048050 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048060 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048070 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048080 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048090 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700048100 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700051020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700063010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700064010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 B3945700068020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. DRG 2026-05-27 00195278990914 Portrait CSSXB Ge Medical Systems Information Technologies, Inc. DRG 2025-12-10 00198953024096 Portrait CVAXB Ge Medical Systems Information Technologies, Inc. DRG 2025-12-10 00198953030981 PORTRAIT HSWXB GE Healthcare Finland Oy DRG 2025-12-10 B353UB12511 UbiqVue Holter Lifesignals, Inc. DRG 2025-04-22 B353UB22511 UbiqVue Holter Lifesignals, Inc. DRG 2025-04-22 B353UA2251DA1 UbiqVue Lifesignals, Inc. DRG 2025-04-22