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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

PF-0001 — Class IIa MDR by Stimuli Technology

MD Atlas
Stimuli Technology

EUDAMED last updated this device on Jul 5, 2024

PF-0001

376031609PF007X

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Stimuli Technology
UDI-DI code: 03760316090139
Reference / catalog number: PF-0001

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Manufacturer information

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

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW030
If you have a pacemaker, defibrillator, or any other electronic implant, as this could cause an electric shock, interference, burns, or cause your pacemaker to malfunction; if you have a metal implant near the stimulated area, as this could result in burns or cause interference with Tensi+; if you have ankle joint problems, swollen ankles or a dermatological condition or damaged skin in the area where the electrodes are to be placed; if you are pregnant; if you have a cognitive impairment. If in doubt, ask your doctor.
CW010
-
CW007
Do not use the product if either the product or packaging is damaged.

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Belgium		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760316090139
Basic UDI-DI: 376031609PF007X
Reference / catalog number: PF-0001
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

N010103BIPOLAR NERVOUS ELECTROSTIMULATORS, BATTERY-POWERED

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 Tensi+ Strap376031609PF017ZOn 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.