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Marquette 9402-046

EUDAMED

Class I (EU MDR)

Ref ACC-BR5030/16 (CSO)Model Accu-PlusRef ACC-BR5030/16(CSO)

by Isd Meditech Sdn. Bhd.

Identity

Trade Name
MARQUETTE 9402-046 EUDAMED
Device Name
Medical Chart Recording Paper EUDAMED
Model / Reference
Accu-Plus EUDAMED
ACC-BR5030/16 (CSO) EUDAMED
ACC-BR5030/16(CSO) EUDAMED

Identifiers

Primary DI / UDI-DI
09551019814665 EUDAMED
Basic UDI-DI
955101981MCRP-APNG EUDAMED
Direct Marketing DI
09551019814665 EUDAMED
EMDN Code
Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED

Classification

Device Class
Class I 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

Marquette 9402-046 by Isd Meditech Sdn. Bhd. — 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

EUDAMED SRN
MY-MF-000043531
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (2)

  • EUDAMED 22757bdd-7c6e-406c-abd1-4a04b70febcf 61 fields · synced Jul 15, 2026
  • EUDAMED 0a39543c-96ae-43ee-98c0-e423c965c3b7 61 fields · synced Jul 15, 2026