Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Eden e 600 - Velours Galène — Class I MDR by Innov'SA

MD Atlas
Innov'SA

EUDAMED last updated this device on Apr 29, 2026

Eden e 600 - Velours Galène

3665533EDENEUK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Innov'SA
UDI-DI code: 03665533124141
Reference / catalog number: EDE4_GALE

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

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 600 - Velours Galène
UDI-DI code: 03665533124141
Basic UDI-DI: 3665533EDENEUK
Reference / catalog number: EDE4_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 roues de 600 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

Related devices

Eden e - Bleu Lagon3665533EDENEUKOn the market Eden e - Gris Chiné3665533EDENEUKOn the market Eden e - Gris Galet3665533EDENEUKOn the market Eden e - Velours Galène3665533EDENEUKOn the market Eden e - Velours Marron3665533EDENEUKOn 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.