Eu Mdd
Eu Md Class 2a
No Longer On The Market
🇫🇮 Finland
Web-ECG
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- D-FI-CA01-2017-1779GX
- Basic UDI-DI Code
- B-FI-CA01-2017-1779GX
- Reference
- 03
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- No Longer On The Market
- Manufacturer
- Oy Diagnostic Devices Development
Additional Description
The Web-ECG software is intended for carrying out ECG diagnostic tests during the screening for cardiac abnormalities. The software is intended for low-risk adults and children in health facilities and at the patient's home by training operator. The software provides authorization, reporting of the results and sending it back to the device, ECG presentation, and measurement of parameters and other service functions. The software includes algorithms for interpretive statements. These statements never can be used as a medical conclusion. The software works with devices TeleCardio, CardioMobile.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V92 | MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex III | VTT-C-12222-1200-628-17 | Eurofins Electric & Electronics Finland Oy | Expired |
Available In Countries
🇬🇷 Greece
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