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Nimbus

EUDAMED

Class IIa (EU MDR)

Ref 649014HUModel 648305BGRef 649014DKRef 649014LVRef 649014RORef 649014LTURef 649020Ref 651201PModel 636C01SRef 649014SERef 649015Ref 649014BGRef 649014SI

by ArjoHuntleigh AB

Identity

Trade Name
Nimbus EUDAMED
Nimbus Professional EUDAMED
Device Name
ALPHA ACTIVE 3 PUMP EUDAMED
AURALIS SEAT CUSHION EUDAMED
Model / Reference
648305BG EUDAMED
649014HU EUDAMED
649014DK EUDAMED
649014LV EUDAMED
649014RO EUDAMED
649014LTU EUDAMED
649020 EUDAMED
636C01S EUDAMED
651201P EUDAMED
649014SE EUDAMED
649015 EUDAMED
649014BG EUDAMED
649014SI EUDAMED

Identifiers

Primary DI / UDI-DI
05055982789127 EUDAMED
05055982784320 EUDAMED
05055982789004 EUDAMED
05055982789011 EUDAMED
05059441150589 EUDAMED
05055982788748 EUDAMED
05055982789516 EUDAMED
05055982784344 EUDAMED
05055982788717 EUDAMED
05056097347196 EUDAMED
05056097347219 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
Hungary EUDAMED
Denmark EUDAMED
Latvia EUDAMED
Romania EUDAMED
Lithuania EUDAMED
Netherlands EUDAMED
Austria EUDAMED
Sweden EUDAMED
France EUDAMED
Bulgaria EUDAMED
Slovenia 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

Nimbus 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

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Manufacturer

Manufacturer
ArjoHuntleigh AB
EUDAMED SRN
SE-MF-000000696

Sources (11)

  • EUDAMED 17473ead-4405-457f-953b-fc4516d987d8 61 fields · synced Sep 17, 2026
  • EUDAMED 18240272-573d-4889-a1bb-f7db182d325f 61 fields · synced May 11, 2026
  • EUDAMED cf6bae59-854e-44df-b587-d700456e4c8b 61 fields · synced May 17, 2026
  • EUDAMED f8bbecc1-0c9c-4b2c-a4e6-a83f84968a0d 61 fields · synced May 17, 2026
  • EUDAMED 3babcde4-d945-4aa0-9f5e-8ef2bad09e72 61 fields · synced May 17, 2026
  • EUDAMED d1cbba0a-80db-4195-8268-4f32eafcc68d 61 fields · synced May 18, 2026
  • EUDAMED bf9411d5-5494-4e77-bbfe-21a60b596b20 61 fields · synced May 18, 2026
  • EUDAMED 9a7bf002-3f20-404f-a2ea-c23de5fd1be0 61 fields · synced May 18, 2026
  • EUDAMED ef35cef8-09b6-4cd2-88a9-2efd4115f352 61 fields · synced May 18, 2026
  • EUDAMED 9f7499e2-2165-456e-9715-73de1d16d6b8 61 fields · synced May 18, 2026
  • EUDAMED 4369ba31-d8f3-4487-9365-8312cc6c4741 61 fields · synced May 19, 2026