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Organization name
UDI-DI code
Reference / catalog number

actiTENS armband (XL size) — Class I MDR by SUBLIMED

MD Atlas
SUBLIMED

EUDAMED last updated this device on Sep 3, 2025

actiTENS armband (XL size)

3770018808ATactiTENS1ZW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SUBLIMED
UDI-DI code: 03770018808116
Reference / catalog number: SBM1AG302

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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 armband (XL size)
UDI-DI code: 03770018808116
Basic UDI-DI: 3770018808ATactiTENS1ZW
Reference / catalog number: SBM1AG302
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 armbands are intended to be placed on any part of the body but not on injured or irritated skin. 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.