Eu Mdr Eu Md Class 1 On The Market 🇫🇷 France

actiTENS self adhesive strip

SUBLIMED · 🇫🇷 France
Devices (same UDI-DI)
1
Certificates
0
Countries
3
Notified Bodies
0

Basic Information

Primary DI
03770018808123
Basic UDI-DI Code
3770018808SAactiTENS128
Reference
SBM1AB001
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
SUBLIMED

Additional Description

The actiTENS EIG can be held on the patient's body thanks to a self-adhesive strip made of a silicone-based adhesive. The self-adhesive strip is intended to be placed on any part of the body but not on injured or irritated skin. The purpose of the self-adhesive strip is to maintain the stimulator near the part of the body which the patient wants to stimulate. The upper face of the self-adhesive strip has a means of fixing composed of 2 strips of velour VELCRO. This means of fixation allows to maintain the actiTENS EIG on the self-adhesive strip. When the stimulation is finished, the patient can place the self-adhesive strip on the liner with which it was packaged. The self-adhesive strip is a consumable. It is recommended to change it every week.

CND Nomenclature Codes

Code Description
Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) [correction as of 2025-01-01]

Available In Countries

🇩🇰 Denmark 🇫🇷 France 🇵🇱 Poland

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