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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

SBM7AA100 — Class IIa MDR by SUBLIMED

MD Atlas
SUBLIMED

EUDAMED last updated this device on Sep 8, 2025

SBM7AA100

3770018808SBMTENSAPPNU

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SUBLIMED
UDI-DI code: 03770018808260
Reference / catalog number: SBM7AA100

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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
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

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	May 13, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03770018808260
Basic UDI-DI: 3770018808SBMTENSAPPNU
Reference / catalog number: SBM7AA100
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: The actiTENS mini is a connected medical device for transcutaneous electrical neurostimulation intended to treat pain in adults and intended for persons over 18 years of age with unimpaired intellectual abilities. The actiTENS mini is fixed directly on to the body using a self-adhesive strip or textile accessory. It adapts to the shape of your body with its flexible design. The actiTENS mini can be used discreetly during your daily activities. It is operated through a smartphone app that allows you to choose from a wide number of stimulation programs and to save all the information recorded from the stimulation treatment sessions. To get the most out of your actiTENS mini, we recommend that a healthcare professional instruct you how to correctly position the electrodes and to select an appropriate stimulation programme for your specific needs.
Additional information URL: https://subli-med.com/wp-content/uploads/2017/11/Notice.pdf%20%20&%20%20https://subli-med.com/wp-content/uploads/2017/11/Notice_en_gb.pdf
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

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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.