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Mortara 9100-026-60

EUDAMED

Class I (EU MDR)

Ref SK-MO-215280-250RS3Model SKYMEDRef ACC-MO215280/250RS3Model Accu-PlusRef SK-MO215280-250RS3

by Isd Meditech Sdn. Bhd.

Identity

Trade Name
MORTARA 9100-026-60 EUDAMED
Device Name
Medical Chart Recording Paper EUDAMED
Model / Reference
SKYMED EUDAMED
SK-MO-215280-250RS3 EUDAMED
Accu-Plus EUDAMED
ACC-MO215280/250RS3 EUDAMED
SK-MO215280-250RS3 EUDAMED

Identifiers

Primary DI / UDI-DI
09551026271017 EUDAMED
09551019814832 EUDAMED
Basic UDI-DI
955102627MCRP-SMMG EUDAMED
955101981MCRP-APNG EUDAMED
Direct Marketing DI
09551026271017 EUDAMED
09551019814832 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 9100-026-60 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 d5edb683-49f7-4672-95d9-6faedf52cbc4 61 fields · synced Jul 30, 2026
  • EUDAMED 382af7b6-39d8-4a3f-9a4d-c9dc5ed2a636 61 fields · synced May 18, 2026
  • EUDAMED eb8557db-5115-4e91-86e6-2e24fca030eb 61 fields · synced Jul 30, 2026