Skip to content

Satroecg

by Satroecg SA EUDAMED

Active European Union

Ref SATROECGV11Model SATROECG v 1.1.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5906660545SATROECG11VP Basic UDI-DIDate19 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • TNP/MDR/0051/4464/2026 Issued

    Quality management system EU MDR

    Notified body
    TUV NORD Polska Sp. z o.o 2274
    Issued
    6 Mar 2026
    Expires
    5 Mar 2029

Specification

EUDAMED

Model / Reference
SATROECG v 1.1., SATROECGV11
Primary DI / UDI-DI
05903968149246
Basic UDI-DI
5906660545SATROECG11VP
EMDN Code
Z12050392 Electrocardiographs - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000044847

Properties

  • 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