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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

FLOWTENS FULL SYSTEM CHEVILLERE… — Class IIa MDR

MD Atlas
Flowstim Technology

EUDAMED last updated this device on May 19, 2025

FLOWTENS FULL SYSTEM CHEVILLERE DROITE

3770025687FT01Z2

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Flowstim Technology
UDI-DI code: 03770025687001
Reference / catalog number: FT01-R

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Manufacturer information

Organization name: Flowstim Technology
SRN: FR-MF-000018490
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Apr 22, 2025	Jul 31, 2040

Device identification

Trade name: FLOWTENS FULL SYSTEM CHEVILLERE DROITE
UDI-DI code: 03770025687001
Basic UDI-DI: 3770025687FT01Z2
Reference / catalog number: FT01-R
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 system consists of the FLOWTENS stimulator medical device, a textile ankle and a recharging cable.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12062780FUNCTIONAL ELECTRICAL STIMULATION SYSTEMS - HARDWARE ACCESSORIES

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

FLOWTENS LEFT ANKLE BRACE3770025687FLO-02-108-R2VOn the market FLOWTENS PATCH3770025687FLO-02-108-R2VOn the market FLOWTENS RIGHT ANKLE BRACE3770025687FLO-02-108-R2VOn the market FLOWTENS STIMULATOR3770025687FLO-02-201ZROn 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.