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Nimbus

EUDAMED

Class IIa (EU MDR)

Ref 649STDModel 648305BG

by ArjoHuntleigh AB

Identity

Trade Name
Nimbus EUDAMED
Device Name
ALPHA ACTIVE 3 PUMP EUDAMED
Model / Reference
648305BG EUDAMED
649STD EUDAMED

Identifiers

Primary DI / UDI-DI
05055982784412 EUDAMED
Basic UDI-DI
5060693520020VD EUDAMED
EMDN Code
Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED

Classification

Device Class
Class IIa 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

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 (1)

  • EUDAMED 67e8f0af-2e22-4e01-bbdf-d7cc1ef06cb3 61 fields · synced Jun 18, 2026