ECG Roll (58mm x 25m)

EUDAMED

Class I (EU MDR)

Ref SK-5825/16RModel SKYMEDRef ACC-5825/16R4Model Accu-PlusRef APP-5825-16R3Model ALPHA-PLUS

by Isd Meditech Sdn. Bhd.

Identity

Trade Name: ECG Roll (58mm x 25m) EUDAMED
ECG ROLL 58MM X 25M EUDAMED
Device Name: Medical Chart Recording Paper EUDAMED
Model / Reference: SKYMED EUDAMED
SK-5825/16R EUDAMED
Accu-Plus EUDAMED
ACC-5825/16R4 EUDAMED
ALPHA-PLUS EUDAMED
APP-5825-16R3 EUDAMED

Identifiers

Primary DI / UDI-DI: 09551019815754 EUDAMED
09551019812869 EUDAMED
09551026272748 EUDAMED
Basic UDI-DI: 955101981MCRP-SMPY EUDAMED
955101981MCRP-APNG EUDAMED
955102627MCRPAPFF EUDAMED
Direct Marketing DI: 09551019815754 EUDAMED
09551019812869 EUDAMED
09551026272748 EUDAMED
EMDN Code: Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED

Classification

Device Class: Class I EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

ECG Roll (58mm x 25m) 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	955101981MCRP-SMPY	Class I	Active

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Manufacturer

Manufacturer: Isd Meditech Sdn. Bhd.
EUDAMED SRN: MY-MF-000043531
Authorised Representative: MDSS GmbH DE-AR-000005430

Sources (3)

EUDAMED d035b7ba-d53f-4f13-ad7f-1df12a028fab 61 fields · synced Jul 29, 2026
EUDAMED 31c732f4-3fae-4ca9-a21d-417b1d441833 61 fields · synced May 19, 2026
EUDAMED 358be549-399b-4917-be6f-0d111cdf9c48 61 fields · synced Jul 9, 2026