Eu Mdd Eu Md Class 2a No Longer On The Market 🇫🇮 Finland

Web-ECG

Oy Diagnostic Devices Development · 🇫🇮 Finland
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

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
MDD Annex III VTT-C-12222-1200-628-17

Available In Countries

🇬🇷 Greece

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