Esaote Power 8000

EUDAMED

Class I (EU MDR)

Ref ACC-S210280/200RS80Model Accu-PlusRef SK-S210280-200RS80Model SKYMEDRef APP-S210280-200RS80Model ALPHA-PLUS

by Isd Meditech Sdn. Bhd.

Identity

Trade Name: ESAOTE POWER 8000 EUDAMED
Device Name: Medical Chart Recording Paper EUDAMED
Model / Reference: Accu-Plus EUDAMED
ACC-S210280/200RS80 EUDAMED
SKYMED EUDAMED
SK-S210280-200RS80 EUDAMED
ALPHA-PLUS EUDAMED
APP-S210280-200RS80 EUDAMED

Identifiers

Primary DI / UDI-DI: 09551019814092 EUDAMED
09551026270232 EUDAMED
09551019819400 EUDAMED
Basic UDI-DI: 955101981MCRP-APNG EUDAMED
955102627MCRP-SMMG EUDAMED
955101981MCRPAPH3 EUDAMED
Direct Marketing DI: 09551019814092 EUDAMED
09551026270232 EUDAMED
09551019819400 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

Esaote Power 8000 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 260ba569-0c7f-458b-ab51-9e66af2dd865 61 fields · synced Jul 16, 2026
EUDAMED 8abfecfe-a3aa-414c-8640-940cef77f059 61 fields · synced May 18, 2026
EUDAMED 401db938-1205-4e21-b86e-df5067600800 61 fields · synced Jun 18, 2026