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ECG Holter recorder EHR-01

by Research and Production Company «Monitor» Limited Russia EUDAMED

Ref -Model ECG Holter recorder EHR-01

EMDN Z12050403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04640003830448 Basic UDI-DIDate29 Oct 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Diagnostic System for Personal Patient Monitoring Spdm 01 Rd
Model / Reference
ECG Holter recorder EHR-01, -
Primary DI / UDI-DI
04640003830448
Basic UDI-DI
B-04640003830448
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
RU-MF-000001877
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 1ba20521-ec5b-4c34-a9ed-05c760a5f6fb 61 fields · synced 22 Oct 2026