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Pupire Douche Opale Sense

EUDAMED

Class I (EU MDR)

Ref 3012.01Model PUPITRE DE DOUCHE

by France Reval

Identity

Trade Name
PUPIRE DOUCHE OPALE SENSE EUDAMED
Device Name
OPALE EUDAMED
Model / Reference
PUPITRE DE DOUCHE EUDAMED
3012.01 EUDAMED

Identifiers

Primary DI / UDI-DI
36664010015642 EUDAMED
Basic UDI-DI
3666401DC002JR EUDAMED
Direct Marketing DI
36664010015642 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

Pupire Douche Opale Sense by France Reval — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

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 eee11ff2-97bf-427e-8bdc-fc6a5bd212ed 61 fields · synced Jul 21, 2026