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4228

EUDAMED

Class I (EU MDR)

Ref 4228Model BATH BOARDS

by Roma Medical Aids

Identity

Model / Reference
BATH BOARDS EUDAMED
4228 EUDAMED

Identifiers

Primary DI / UDI-DI
05055721201620 EUDAMED
Basic UDI-DI
5055721241051UG EUDAMED
EMDN Code
Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Czechia 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

4228 by Roma Medical Aids — 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
Roma Medical Aids
EUDAMED SRN
GB-MF-000013502
Authorised Representative
StartDock Rotterdam B.V. NL-AR-000012537

Sources (1)

  • EUDAMED 740d1a40-a173-4bd5-a98f-9540cb9600ec 61 fields · synced Jul 12, 2026