- Organization name
- UDI-DI code
- Reference / catalog number
TW-MF-000026397TW19/20042EZYPRO Wearable ECG System – EZYPRO ECG Recorder, SIGKNOW ECG Patch, accessories, supporting software, and EZYPRO Analyzer is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Sigknow Biomedical Co., Ltd.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Sep 3, 2026
B-04719875010309Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04719875010309
1 warning recorded — scroll inside the panel to see all entries.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Czechia; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Mar 1, 2021 | Still on market |
| EL | Mar 1, 2023 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04719875010309Basic 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-04719875010309UG02UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
C020501ECG ELECTRODESC020599CARDIAC DIAGNOSTIC DEVICES - OTHERB-04719875010293On the marketEZYPRO Wearable ECG System – EZYPRO ECG Recorder, SIGKNOW ECG Patch, accessories, supporting software, and EZYPRO AnalyzerB-04719875010132On the marketEZYPRO Wearable ECG System – EZYPRO ECG Recorder, SIGKNOW ECG Patch, accessories, supporting software, and EZYPRO AnalyzerB-04719875010484On the marketSIGKNOW EZYPRO ECG Patch UG02-P0471987501PATCH6GOn the marketSIGKNOW EZYPRO ECG Patch UG02-P0471987501PATCH6GOn the marketNo certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.