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Ultrasound Paper 84mm x 12.5m (High Glossy, Type V) ACCU-PLUS

EUDAMED

Class I (EU MDR)

Ref ACC-84HGModel Accu-PlusRef SM84HGModel SKYMED

by Isd Meditech Sdn. Bhd.

Identity

Trade Name
Ultrasound Paper 84mm x 12.5m (High Glossy, Type V) ACCU-PLUS EUDAMED
Ultrasound Paper 84mm x 12.5m (High Glossy, Type V) Skymed EUDAMED
Device Name
Ultrasound Paper EUDAMED
Model / Reference
Accu-Plus EUDAMED
ACC-84HG EUDAMED
SKYMED EUDAMED
SM84HG EUDAMED

Identifiers

Primary DI / UDI-DI
09551019812647 EUDAMED
09551019812524 EUDAMED
Basic UDI-DI
955101981USP-APL3 EUDAMED
955101981USP-SMMK EUDAMED
Direct Marketing DI
09551019812647 EUDAMED
09551019812524 EUDAMED
EMDN Code
Z11040185 ULTRASOUND SCANNERS - CONSUMABLES 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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Ultrasound Paper 84mm x 12.5m (High Glossy, Type V) ACCU-PLUS 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

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

Sources (4)

  • EUDAMED 62da51ec-0e84-4504-b522-f707017fb4c3 61 fields · synced Oct 6, 2026
  • EUDAMED 56329449-4e4b-4b89-806e-a3d26e8cf97e 61 fields · synced May 18, 2026
  • EUDAMED a04d5b62-7682-4d16-a8dc-f8c72fce7818 61 fields · synced Jun 18, 2026
  • EUDAMED 2b1b3675-e846-457b-b02c-557b95bebb94 61 fields · synced Jul 17, 2026