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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

actiTENS belt/ bra accessory — Class I MDR by SUBLIMED

MD Atlas
SUBLIMED

EUDAMED last updated this device on Sep 3, 2025

actiTENS belt/ bra accessory

3770018808ATactiTENS1ZW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SUBLIMED
UDI-DI code: 03770018808086
Reference / catalog number: SBM1AG400

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Manufacturer information

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

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Mar 14, 2019	Still on market

Device identification

Trade name: actiTENS belt/ bra accessory
UDI-DI code: 03770018808086
Basic UDI-DI: 3770018808ATactiTENS1ZW
Reference / catalog number: SBM1AG400
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The actiTENS EIG can be held on the patient's body thanks to a textile accessory. The belt/bra accessory is intended to be placed on the belt/bra. The purpose of the Textile accessories is to maintain actiTENS EIG near the part of the body which the patient wants to stimulate.
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.