← Back to catalogue

Auralis

EUDAMED

Class IIa (EU MDR)

Ref 636002PLModel 648305BGRef 636002NLRef 636002LVRef 636002LTURef 636002HRRef 636M05SModel 636C01SRef 636002NORef 636002SLRef 636002DKRef 636018Ref 636002SERef 636002PTRef 636002BERef 636002ITRef 636002FRRef 636002TRRef 636002IE

by ArjoHuntleigh AB

Identity

Trade Name
Auralis EUDAMED
Device Name
ALPHA ACTIVE 3 PUMP EUDAMED
AURALIS SEAT CUSHION EUDAMED
Model / Reference
648305BG EUDAMED
636002PL EUDAMED
636002NL EUDAMED
636002LV EUDAMED
636002LTU EUDAMED
636002HR EUDAMED
636C01S EUDAMED
636M05S EUDAMED
636002NO EUDAMED
636002SL EUDAMED
636002DK EUDAMED
636018 EUDAMED
636002SE EUDAMED
636002PT EUDAMED
636002BE EUDAMED
636002IT EUDAMED
636002FR EUDAMED
636002TR EUDAMED
636002IE EUDAMED

Identifiers

Primary DI / UDI-DI
05056341675549 EUDAMED
05056341675525 EUDAMED
05059441130802 EUDAMED
05059441150558 EUDAMED
05059441130772 EUDAMED
05056341675365 EUDAMED
05056341675532 EUDAMED
05059441130840 EUDAMED
05056341675495 EUDAMED
05059441141808 EUDAMED
05056341675556 EUDAMED
05059441134756 EUDAMED
05056341675471 EUDAMED
05056341675518 EUDAMED
05056341675501 EUDAMED
05059441133858 EUDAMED
05056341698616 EUDAMED
Basic UDI-DI
5060693520020VD EUDAMED
5060693520136VZ EUDAMED
EMDN Code
Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class I EUDAMED
Market of Registration
Poland EUDAMED
Netherlands EUDAMED
Latvia EUDAMED
Lithuania EUDAMED
Croatia EUDAMED
Austria EUDAMED
Norway EUDAMED
Slovenia EUDAMED
Denmark EUDAMED
Sweden EUDAMED
Portugal EUDAMED
Belgium EUDAMED
Italy EUDAMED
France EUDAMED
Türkiye EUDAMED
Ireland 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

Auralis by Arjohuntleigh AB — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ArjoHuntleigh AB
EUDAMED SRN
SE-MF-000000696

Sources (17)

  • EUDAMED de6efeab-d39a-4b35-82cb-2d99d1ca4da0 61 fields · synced Jul 25, 2026
  • EUDAMED 085e38ce-9560-40ae-a278-66b55770f696 61 fields · synced May 11, 2026
  • EUDAMED cbfdb2fc-ab2d-4ee1-ae90-8d825904b07e 61 fields · synced May 16, 2026
  • EUDAMED fc927afa-f443-4a34-8060-52992b711ab3 61 fields · synced May 16, 2026
  • EUDAMED b1014392-45c1-46ba-a3e9-777e6aa2ac6f 61 fields · synced May 17, 2026
  • EUDAMED 37688586-2fcd-462b-b8f6-f28237b6a3e6 61 fields · synced May 17, 2026
  • EUDAMED 15962a4b-fb53-4afd-82fd-36951243dd94 61 fields · synced May 17, 2026
  • EUDAMED df75448f-4e72-4535-902b-6e696574d4e2 61 fields · synced May 17, 2026
  • EUDAMED 720351bb-5861-4131-9d77-392265112e4f 61 fields · synced May 17, 2026
  • EUDAMED 574eef2d-8365-482a-bda9-61cf0906d50a 61 fields · synced May 18, 2026
  • EUDAMED 922b8e2b-bfa5-42bd-8e20-646ba31d117c 61 fields · synced May 18, 2026
  • EUDAMED ff620e73-05df-4e4c-bee6-f923d13b2e08 61 fields · synced May 18, 2026
  • EUDAMED 4a76b5a0-2125-49d5-8cc5-b9562652a901 61 fields · synced May 18, 2026
  • EUDAMED 82dd065f-e8ea-4c2c-8ea2-ceb24c095192 61 fields · synced May 18, 2026
  • EUDAMED d8cbb821-3cec-4f1f-9ead-0464d70646be 61 fields · synced May 19, 2026
  • EUDAMED c9ffbb9a-a9da-45aa-b6fe-836d7c73b535 61 fields · synced May 19, 2026
  • EUDAMED 3e422e76-2522-4c60-8145-cb2fe6d22134 61 fields · synced May 19, 2026