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Space Labs Ms1r-107371-Ao

EUDAMED

Class I (EU MDR)

Ref ACC-SP210295/100RSModel Accu-Plus

by Isd Meditech Sdn. Bhd.

Identity

Trade Name
SPACE LABS MS1R-107371-AO EUDAMED
Device Name
Medical Chart Recording Paper EUDAMED
Model / Reference
Accu-Plus EUDAMED
ACC-SP210295/100RS EUDAMED

Identifiers

Primary DI / UDI-DI
09551019815266 EUDAMED
Basic UDI-DI
955101981MCRP-APNG EUDAMED
Direct Marketing DI
09551019815266 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

Space Labs Ms1r-107371-Ao 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 (1)

  • EUDAMED a8a6791e-a3e6-4823-8722-1e7e63640a31 61 fields · synced Jul 9, 2026