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Soflex Hydraulique

EUDAMED

Class I (EU MDR)

Ref 5601.00Model FAUTEUIL ELEVATEUR DE DOUCHE

by France Reval

Identity

Trade Name
SOFLEX HYDRAULIQUE EUDAMED
Device Name
SOFLEX EUDAMED
Model / Reference
FAUTEUIL ELEVATEUR DE DOUCHE EUDAMED
5601.00 EUDAMED

Identifiers

Primary DI / UDI-DI
36664010001300 EUDAMED
Basic UDI-DI
3666401DC006JZ EUDAMED
Direct Marketing DI
36664010001300 EUDAMED
EMDN Code
Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Hydrotherapy bath/tank

Soflex Hydraulique by France Reval — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Hydrotherapy bath/tank.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
France Reval
EUDAMED SRN
FR-MF-000011523

Sources (1)

  • EUDAMED 75283ae4-254a-4952-bb71-e5ea38ef7b31 61 fields · synced Jul 9, 2026