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OPUS1

by String Polska Sp. z o.o. Poland EUDAMED

Ref 12CHECGOPUS1Model OPUS1

EMDN Z12050302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberTNP/MDR/0052/4887/2026 Date10 Mar 2026IssuedStatusActive expires 9 Mar 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • TNP/MDR/0052/4887/2026 Issued

    Quality management system EU MDR

    Notified body
    TUV NORD Polska Sp. z o.o 2274
    Issued
    10 Mar 2026
    Expires
    9 Mar 2029

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Electrocardiograph OPUS1
Model / Reference
OPUS1, 12CHECGOPUS1
Primary DI / UDI-DI
59051084491174
Basic UDI-DI
5905108449112CHECGOPUS1TV
EMDN Code
Z12050302 Advanced diagnosis electrocardiographs
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000035907

Other devices from String Polska Sp. z o.o.

  • OPUS mini

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 5581ca0e-e1b9-437e-98ce-2311723e6a54 61 fields · synced 22 Oct 2026