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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

Tensi+ Strap — Class I MDR by Stimuli Technology

MD Atlas
Stimuli Technology

EUDAMED last updated this device on Apr 9, 2025

Tensi+ Strap

376031609PF017Z

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Stimuli Technology
UDI-DI code: 03760316090146
Reference / catalog number: PF0109

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Manufacturer information

Organization name: Stimuli Technology
SRN: FR-MF-000002429
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: Tensi+ Strap
UDI-DI code: 03760316090146
Basic UDI-DI: 376031609PF017Z
Reference / catalog number: PF0109
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: Tensi+ Strap is a spare-part of the Tensi+ device, designed to position the Tensi+ on the patient's ankle. The Tensi+ device is a neuromuscular electro stimulator for self-treatment, at home, directly used by patient to treat the Overactive Bladder syndrome (OAB) by stimulating tibial posterior nerve using nerve stimulation technique.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M03030199ELASTIC FIXING BANDAGES - OTHER

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

PF-0001376031609PF007XOn the market PF-0001376031609PF007XOn 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.