Organization name

Sigknow Biomedical Co., Ltd.

SRN

TW-MF-000026397

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• CW015

  EUDAMED did not publish a description for this code.
• CW023

  MR UNSAFE
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Czechia; available across 2 countries total.

Trade name

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

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

04719875010132

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-04719875010132

Reference / catalog number

UG02

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product 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 18 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. Package contents: One ECG recorder and one ECG patch, with a 14-day service ID.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• C020501ECG ELECTRODES
• C020599CARDIAC DIAGNOSTIC DEVICES - OTHER

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.