CARDIOLINE SPA

Address:Via Linz 151,TRENTO,IT

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrocardiograph (DPS) (2) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (1)

Premarket Exempt

Clear

ECG100+ - 08056732653610 Catalog Number : 80508095

Device Description : 12‐lead high‐performance, multi‐channel, interpretative resting electrocardiogra 12‐lead high‐performance, multi‐channel, interpretative resting electrocardiograph which displays, acquires, prints and stores ECG tracings for adults and children. 4.3" display and 100mm printer paper.

Device Class : 2

Duns Number: 339465174

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

touchECG - 08056732654587 Catalog Number : 81019579

Device Description : Software that implements a multichannel interpretative electrocardiograph design Software that implements a multichannel interpretative electrocardiograph designed to check and diagnose cardiac function.

Device Class : 2

Duns Number: 339465174

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

HD+ - 08056732654594 Catalog Number : 81018027

Device Description : Digital portable acquisition device which can acquire the electrocardiographic s Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth, sends the data to the host.

Device Class : 2

Duns Number: 339465174

Premarket Exempt : No

Product Code : DRG

Prescription Use : Yes

Device Count : 1

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