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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

Eden e - Velours Galène — Class I MDR by Innov'SA

MD Atlas
Innov'SA

EUDAMED last updated this device on Apr 28, 2026

Eden e - Velours Galène

3665533EDENEUK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Innov'SA
UDI-DI code: 03665533055896
Reference / catalog number: EDE2_GALE

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Manufacturer information

Organization name: Innov'SA
SRN: FR-MF-000006814
Manufacturer status: Active

Related devices

Eden e - Bleu Lagon3665533EDENEUKOn the market Eden e - Gris Chiné3665533EDENEUKOn the market Eden e - Gris Galet3665533EDENEUKOn the market Eden e - Velours Marron3665533EDENEUKOn the market Eden e - Velours Saphir3665533EDENEUKOn 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.

Critical warnings

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

CW010
Toujours consulter la notice d'utilisation avant la première utilisation

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	May 4, 2026	Still on market

Device identification

Trade name: Eden e - Velours Galène
UDI-DI code: 03665533055896
Basic UDI-DI: 3665533EDENEUK
Reference / catalog number: EDE2_GALE
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: EDEN inclinaison électrique Velours Galène
Additional information URL: https://www.innov-sa.com/details-fauteuil+roulant+eden+e-186.html
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y122103PUSH WHEELCHAIRS

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