Eu Mdd
Eu Md Class 2a
On The Market
๐น๐ผ Taiwan
EZYPRO ECG Recorder
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 04719875010132
- Basic UDI-DI Code
- B-04719875010132
- Reference
- UG02
- Device Types
-
Single use
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Sigknow Biomedical Co., Ltd.
Additional 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. EZYPRO ECG Recorder (Model: UG02) is equipped with an advanced ECG Recorder and a convenient single-use, replaceable ECG Patch.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C020501 | ECG ELECTRODES |
| C020599 | CARDIAC DIAGNOSTIC DEVICES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | TW19/20042 | SGS Belgium NV | Expired |
Available In Countries
๐จ๐ฟ Czechia
๐ฌ๐ท Greece
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