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Marquette 9402-021

EUDAMED

Class I (EU MDR)

Ref ACC-MQ210280/300RModel Accu-PlusRef APP-MQ210280-300RModel ALPHA-PLUS

by Isd Meditech Sdn. Bhd.

Identity

Trade Name
MARQUETTE 9402-021 EUDAMED
Device Name
Medical Chart Recording Paper EUDAMED
Model / Reference
Accu-Plus EUDAMED
ACC-MQ210280/300R EUDAMED
ALPHA-PLUS EUDAMED
APP-MQ210280-300R EUDAMED

Identifiers

Primary DI / UDI-DI
09551019811091 EUDAMED
09551026271789 EUDAMED
Basic UDI-DI
955101981MCRP-APNG EUDAMED
955102627MCRPAPFF EUDAMED
Direct Marketing DI
09551019811091 EUDAMED
09551026271789 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 9402-021 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 519aa494-ae32-4e39-b651-fda59367eee5 61 fields · synced Jul 31, 2026
  • EUDAMED fa540b7c-803b-4fb7-82b2-726d1681f328 61 fields · synced Jul 31, 2026