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Mortara 9100-026-51

EUDAMED

Class I (EU MDR)

Ref SK-MO-210300-250RS1Model SKYMEDRef ACC-MO210300/250RS1Model Accu-PlusRef SK-MO210300-250RS1

by Isd Meditech Sdn. Bhd.

Identity

Trade Name
MORTARA 9100-026-51 EUDAMED
Device Name
Medical Chart Recording Paper EUDAMED
Model / Reference
SKYMED EUDAMED
SK-MO-210300-250RS1 EUDAMED
Accu-Plus EUDAMED
ACC-MO210300/250RS1 EUDAMED
SK-MO210300-250RS1 EUDAMED

Identifiers

Primary DI / UDI-DI
09551019810599 EUDAMED
09551019811121 EUDAMED
Basic UDI-DI
955101981MCRP-SMPY EUDAMED
955101981MCRP-APNG EUDAMED
Direct Marketing DI
09551019810599 EUDAMED
09551019811121 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

Mortara 9100-026-51 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 (3)

  • EUDAMED eb6d68a0-6ce8-4a9a-9b02-37a01e06ee4b 61 fields · synced Oct 7, 2026
  • EUDAMED b1763439-428f-4601-b970-05a06438e823 61 fields · synced May 18, 2026
  • EUDAMED 4e53765d-eed7-4ac6-b9c5-707254402321 61 fields · synced Jun 18, 2026