Eu Mdr Eu Md Class 2a On The Market

TELECARDIOCALM

TELECRADIOCALM is a remote telemedicine system that enables facilities distributed across the territory to perform diagnostic cardiological exams (ECG/Holter ECG/Blood Pressure Holter) and send them via the Internet for reporting by properly authorized cardiologists. The digitally signed report is then returned via the Internet.

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
+B972CC01020B
Basic UDI-DI Code
++B972TELECC32W
Reference
CC0102
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

Telecardiology system

Medical Purpose

TELECRADIOCALM is a remote telemedicine system that enables facilities distributed across the territory to perform diagnostic cardiological exams (ECG/Holter ECG/Blood Pressure Holter) and send them via the Internet for reporting by properly authorized cardiologists. The digitally signed report is then returned via the Internet.

CND Nomenclature Codes

Code Description
Z12050403 ECG HOLTER RECORDERS
Z12050404 BLOOD PRESSURE HOLTER RECORDERS
Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS
Z12050482 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES
Z12050382 ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES

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