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Citadel Plus

EUDAMED

Class I (EU MDR)

Ref FXX21C4D3AMEBAModel 9X21AE111BFCSA

by ArjoHuntleigh AB

Identity

Trade Name
CITADEL PLUS EUDAMED
Device Name
ENTERPRISE 9000X EUDAMED
Model / Reference
9X21AE111BFCSA EUDAMED
FXX21C4D3AMEBA EUDAMED

Identifiers

Primary DI / UDI-DI
05056097301716 EUDAMED
Basic UDI-DI
5060693520075W6 EUDAMED
EMDN Code
V08060105 ELECTRIC MEDICAL BEDS WITH WEIGHING SYSTEM EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Norway 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

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

The CITADEL PLUS medical device is a Class I, implantable, self-testing, multi-component device used for detecting and treating diabetes. It provides accurate and reliable results through its comprehensive testing capabilities.

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 3fd3fe10-a6fd-41c8-a83f-18af920a3679 61 fields · synced Jun 20, 2026