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Anti-Bedsore Seat Cushion

EUDAMED

Class I (EU MDR)

Ref BioFlote 2 PlusModel BioFlote 2 Plus/40

by REHA FUND Sp. z o.o.

Identity

Trade Name
ANTI-BEDSORE SEAT CUSHION EUDAMED
Device Name
PODUSZKA PRZECIWODLEŻYNOWA DO SIEDZENIA EUDAMED
Model / Reference
BioFlote 2 Plus/40 EUDAMED
BioFlote 2 Plus EUDAMED

Identifiers

Primary DI / UDI-DI
05903940700212 EUDAMED
Basic UDI-DI
59039407BF2WP EUDAMED
Direct Marketing DI
05903940700212 EUDAMED
EMDN Code
V080399 MEDICAL CUSHIONS - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Poland 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

Anti-Bedsore Seat Cushion by REHA FUND Sp. z o.o. — 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

EUDAMED SRN
PL-MF-000047481

Sources (1)

  • EUDAMED be328ca2-da0d-4cd8-8e88-abf7f45ca699 61 fields · synced Oct 7, 2026