Skip to content

CardioWaver

by SynexCare sp. z o.o. Poland EUDAMED

Ref 1002100000

EMDN Z12050403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberTNP/MDR/0041/5915/2025 Date11 Sep 2025IssuedStatusActive expires 10 Sep 2028

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • TNP/MDR/0041/5915/2025 Issued

    Quality management system EU MDR

    Notified body
    TUV NORD Polska Sp. z o.o 2274
    Issued
    11 Sep 2025
    Expires
    10 Sep 2028

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Rejestrator holterowski EKG
Model / Reference
1002100000
Primary DI / UDI-DI
05905471789018
Basic UDI-DI
590547178901002QB
Direct Marketing DI
05905471789018
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000038028

Other devices from SynexCare sp. z o.o.

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 6550dd83-cd05-404c-8527-5797e9c7cc4f 61 fields · synced 22 Oct 2026