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Organization name
UDI-DI code
Reference / catalog number

VitaliTENS — Class IIa MDR by SUBLIMED

MD Atlas
SUBLIMED

EUDAMED last updated this device on Mar 6, 2025

VitaliTENS

3770018808SBMTENSAPPNU

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SUBLIMED
UDI-DI code: 03770018808055
Reference / catalog number: 8703703

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Manufacturer information

Organization name: SUBLIMED
SRN: FR-MF-000007546
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW030
The VitaliTENS should not be used on the following patients without medical advice: - Patients with pacemakers, implantable cardioverter defibrillators, or other similar electronic implantable devices. - Patients at risk of heart problems. - Patients with epilepsy. - Patients with decreased or impaired sensation or sensibility on the area to be treated, for example patients suffering from allodynia (pain triggered by a normally painless stimulus). - VitaliTENS should not be used on pregnant women without medical advice. The electrodes must not be placed on the abdomen of a pregnant woman. Failure to respect these contra-indications may have serious consequences and be harmful to the patient.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jun 7, 2023	Still on market

Device identification

Trade name: VitaliTENS
UDI-DI code: 03770018808055
Basic UDI-DI: 3770018808SBMTENSAPPNU
Reference / catalog number: 8703703
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: VitaliTENS est un dispositif médical de neurostimulation électrique transcutanée destiné à traiter les douleurs chroniques des adultes souffrant d'arthrose du genou. VitaliTENS se fixe directement sur le corps à l'aide d'un accessoire dédié. Il s'adapte à la forme de votre corps grâce à sa conception flexible. VitaliTENS peut être utilisé en toute discrétion pendant vos activités quotidiennes. Il fonctionne grâce à une application smartphone qui vous permet de choisir parmi plusieurs programmes de stimulation et de sauvegarder toutes les informations enregistrées lors des séances de traitement par stimulation. VitaliTENS partage le même développement que le produit actiTENS, il est destiné à soulager les douleurs chroniques dans le cadre de la gonarthrose. Il s'agit donc d'une réduction du champ d'application de l'actiTENS.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120601ELECTROTHERAPY EQUIPMENT (INCLUDED TENS)

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Accessoire ceinture/ soutien gorge VitaliTENS3770018808ATVitaliTENS1PKOn the market actiTENS Android app3770018808SBMTENSAPPNUOn the market actiTENS armband (Standard size)3770018808ATactiTENS1ZWOn the market actiTENS armband (XL size)3770018808ATactiTENS1ZWOn the market actiTENS armband (XS size)3770018808ATactiTENS1ZWOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.