Fukuda Cardisuny 063f30-H03 / Op-219te

EUDAMED

Class I (EU MDR)

Ref ACC-FC63100/300RS1Model Accu-PlusRef SK-FC-63100-300RS1Model SKYMEDRef SK-FC63100-300RS1

by Isd Meditech Sdn. Bhd.

Identity

Trade Name: FUKUDA CARDISUNY 063F30-H03 / OP-219TE EUDAMED
FUKUDA CARDISUNY 063F30-H03/OP-219TE EUDAMED
Device Name: Medical Chart Recording Paper EUDAMED
Model / Reference: Accu-Plus EUDAMED
ACC-FC63100/300RS1 EUDAMED
SKYMED EUDAMED
SK-FC-63100-300RS1 EUDAMED
SK-FC63100-300RS1 EUDAMED

Identifiers

Primary DI / UDI-DI: 09551019814153 EUDAMED
09551026270256 EUDAMED
Basic UDI-DI: 955101981MCRP-APNG EUDAMED
955102627MCRP-SMMG EUDAMED
Direct Marketing DI: 09551019814153 EUDAMED
09551026270256 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

Fukuda Cardisuny 063f30-H03 / Op-219te 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-APNG	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 4b5b692d-acaf-4e92-a610-8bf0a323ef5d 61 fields · synced Oct 6, 2026
EUDAMED 0b40bcff-a0dc-4160-bd45-20dfd0525e0b 61 fields · synced May 18, 2026
EUDAMED 8b09af06-9473-4c99-9f21-a7d93dd8e5e5 61 fields · synced Jul 28, 2026