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Toitu 0030-023

EUDAMED

Class I (EU MDR)

Ref ACC-TT152150/200GNSModel Accu-PlusRef SK-TT-152150-200GNSModel SKYMEDRef APP-TT152150-200GNSModel ALPHA-PLUSRef SK-TT152150-200GNS

by Isd Meditech Sdn. Bhd.

Identity

Trade Name
TOITU 0030-023 EUDAMED
Device Name
Medical Chart Recording Paper EUDAMED
Model / Reference
Accu-Plus EUDAMED
ACC-TT152150/200GNS EUDAMED
SKYMED EUDAMED
SK-TT-152150-200GNS EUDAMED
ALPHA-PLUS EUDAMED
APP-TT152150-200GNS EUDAMED
SK-TT152150-200GNS EUDAMED

Identifiers

Primary DI / UDI-DI
09551019815303 EUDAMED
09551026271475 EUDAMED
09551026273455 EUDAMED
Basic UDI-DI
955101981MCRP-APNG EUDAMED
955102627MCRP-SMMG EUDAMED
955102627MCRPAPFF EUDAMED
Direct Marketing DI
09551019815303 EUDAMED
09551026271475 EUDAMED
09551026273455 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

Toitu 0030-023 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 (4)

  • EUDAMED d4e2bf10-f41b-406f-8988-ae21243da3d6 61 fields · synced Jul 31, 2026
  • EUDAMED 7990391c-675f-41ef-bf5a-67a57efbdc22 61 fields · synced May 17, 2026
  • EUDAMED 7d6559b7-73e3-4072-82ce-0d6c5e12ec32 61 fields · synced Jul 29, 2026
  • EUDAMED 94764ea1-05cd-47b3-b17e-3319b86beff1 61 fields · synced Jul 31, 2026