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Hellige Marquette 2261 6611-2261 6605

EUDAMED

Class I (EU MDR)

Ref SK-HM-210295-150RSModel SKYMEDRef SK-HM210295-150RS

by Isd Meditech Sdn. Bhd.

Identity

Trade Name
HELLIGE MARQUETTE 2261 6611-2261 6605 EUDAMED
HELLIGE MARQUETTE 2261 6611/2261 6605 EUDAMED
Device Name
Medical Chart Recording Paper EUDAMED
Model / Reference
SKYMED EUDAMED
SK-HM-210295-150RS EUDAMED
SK-HM210295-150RS EUDAMED

Identifiers

Primary DI / UDI-DI
09551019810254 EUDAMED
Basic UDI-DI
955101981MCRP-SMPY EUDAMED
Direct Marketing DI
09551019810254 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

Hellige Marquette 2261 6611-2261 6605 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 81b0bf11-7616-4561-911d-c76edc9810aa 61 fields · synced Jun 18, 2026
  • EUDAMED 28d9af5d-c83c-42dd-9822-1d94661eece7 61 fields · synced Jun 18, 2026