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EUDAMED last updated this device on Jun 22, 2026
3770018808SBMTENSAPPNUactiTENS mini is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by SUBLIMED. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
03770018808260SBM7AA100(01)03770018808260
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z120601ELECTROTHERAPY EQUIPMENT (INCLUDED TENS)1 warning recorded — scroll inside the panel to see all entries.
Consult healthcare professional before use-(Description)The actiTENS mini 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). - actiTENS mini 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
Primary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | May 13, 2025 | Still on market |
FR-MF-000007546The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →3770018808ATactiTENS1ZWOn the marketactiTENS belt/ bra accessory3770018808ATactiTENS1ZWOn the marketactiTENS iOS app3770018808SBMTENSAPPNUOn the marketactiTENS self adhesive strip3770018808SAactiTENS128On the marketApplication mobile VitaliTENS pour Android3770018808SBMTENSAPPNUOn the marketApplication mobile VitaliTENS pour iOS3770018808SBMTENSAPPNUOn the marketNo certificate specifically references this device's Basic UDI-DI.
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.