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Pupitre Douche Opal

EUDAMED

Class I (EU MDR)

Ref 3011.00Model PUPITRE DE DOUCHE

by France Reval

Identity

Trade Name
PUPITRE DOUCHE OPAL EUDAMED
Device Name
OPALE EUDAMED
Model / Reference
PUPITRE DE DOUCHE EUDAMED
3011.00 EUDAMED

Identifiers

Primary DI / UDI-DI
36664010016014 EUDAMED
Basic UDI-DI
3666401DC002JR EUDAMED
Direct Marketing DI
36664010016014 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

Pupitre Douche Opal 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 2ddf01bc-1eb9-47be-a184-4dd58f2a2151 61 fields · synced Jun 19, 2026