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Cambridge 60-0000-001

EUDAMED

Class I (EU MDR)

Ref ACC-CAM215280/250RSModel Accu-PlusRef SK-CAM215280-250RSModel SKYMED

by Isd Meditech Sdn. Bhd.

Identity

Trade Name
CAMBRIDGE 60-0000-001 EUDAMED
Device Name
Medical Chart Recording Paper EUDAMED
Model / Reference
Accu-Plus EUDAMED
ACC-CAM215280/250RS EUDAMED
SKYMED EUDAMED
SK-CAM215280-250RS EUDAMED

Identifiers

Primary DI / UDI-DI
09551019813613 EUDAMED
09551019811978 EUDAMED
Basic UDI-DI
955101981MCRP-APNG EUDAMED
955101981MCRP-SMPY EUDAMED
Direct Marketing DI
09551019813613 EUDAMED
09551019811978 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

Cambridge 60-0000-001 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 (2)

  • EUDAMED fb749e71-3c8c-4daa-94b5-56b6d7b5c085 61 fields · synced Jul 14, 2026
  • EUDAMED 29bc24b3-6a30-408b-a620-50911e8eaff9 61 fields · synced Jul 10, 2026