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

CardioMobile

Oy Diagnostic Devices Development · 🇫🇮 Finland
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1

Basic Information

Primary DI
D-FI-CA-01-2017-1780DZ
Basic UDI-DI Code
B-FI-CA-01-2017-1780DZ
Reference
04
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
No Longer On The Market

Additional Description

The CardioMobile electrocardiograph is intended for the ECG tests by healthcare professionals for the patients of age 12+ in health facilities and also visiting patients at home. The device provides the following diagnostic functions: - acquiring, viewing, and storage of the ECG waveforms using a patient cable and associated accessories that provide signal acquisition for up to 12 ECG-leads - transmitting the collected data using digital or analog communication channels for the consultation and receiving the physicians' report

CND Nomenclature Codes

Code Description
Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS

Certificates

Type Number
MDD Annex II (excluding section 4) VTT-C-12222-01-1200-628-17

Available In Countries

🇫🇮 Finland

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