Eu Mdr Eu Md Class 2a On The Market 🇮🇹 Italy

PulsePen

DiaTecne s.r.l. · 🇮🇹 Italy
Devices (same UDI-DI)
2
Certificates
0
Countries
3
Notified Bodies
0

Basic Information

Primary DI
08059388230020
Basic UDI-DI Code
80593882300UE
Reference
WPP001-ETT
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
DiaTecne s.r.l.

Additional Description

PulsePen is an active medical device, for diagnostic purposes, intended for recording the blood pressure curve and evaluating the arterial stiffness through the non-invasive method of "applanation tonometry". The primary functions are the acquisition, display, and storage of the arterial pressure signals to subsequently proceed with calculating the relevant parameters, including the pulse wave velocity (Pulse Wave Velocity - PWV) related to arterial stiffness.

CND Nomenclature Codes

Code Description
Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER

Available In Countries

🇦🇹 Austria 🇮🇹 Italy 🇸🇪 Sweden

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The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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