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Alpha Active 3

EUDAMED

Class I (EU MDR)

Ref 648342Model 636C01S

by ArjoHuntleigh AB

Identity

Trade Name
Alpha Active 3 EUDAMED
Device Name
AURALIS SEAT CUSHION EUDAMED
Model / Reference
636C01S EUDAMED
648342 EUDAMED

Identifiers

Primary DI / UDI-DI
05055982781039 EUDAMED
Basic UDI-DI
5060693520136VZ EUDAMED
EMDN Code
V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria 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

Alpha Active 3 by Arjohuntleigh AB — 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
ArjoHuntleigh AB
EUDAMED SRN
SE-MF-000000696

Sources (1)

  • EUDAMED dda8a092-9bc1-4f4d-bfc8-ebdba09e3d47 61 fields · synced Jun 18, 2026