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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

SOFLEX HYDRAULIQUE — Class I MDR by France Reval

MD Atlas
France Reval

EUDAMED last updated this device on Jan 9, 2026

SOFLEX HYDRAULIQUE

3666401DC006JZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: France Reval
UDI-DI code: 36664010014416
Reference / catalog number: 5606.00

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Manufacturer information

Organization name: France Reval
SRN: FR-MF-000011523
Manufacturer status: Active

Critical warnings

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

CW999
Toujours vérifier les freins avant toutes opérations. Toujours faire rouler ou manœuvrer la chaise en position basse. Ne jamais laisser le patient sans surveillance. Ne jamais dépasser la charge maxi. Lire et comprendre le manuel d'utilisation avant la première utilisation

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: SOFLEX HYDRAULIQUE
UDI-DI code: 36664010014416
Basic UDI-DI: 3666401DC006JZ
Reference / catalog number: 5606.00
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: La chaise de douche élévatrice SOFLEX est destinée aux transferts et à la douche des patients.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y093399WASHING, BATHING AND SHOWERING DEVICES - 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

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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.