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Mobil-O-Graph PWA

by IEM GmbH Germany EUDAMED

Ref 070402001, 070302002Model Amedtec ECGpro Holter-RR USB-C, Scanlight by IEM USB-C

EMDN Z12050404

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04041346102412 Basic UDI-DIDate2 Sep 2025RegisteredStatusActive

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 25 Oct 2026

Device Name
Mobil-O-Graph PWA
Model / Reference
Amedtec ECGpro Holter-RR USB-C, 070402001, Scanlight by IEM USB-C, 070302002
Primary DI / UDI-DI
04041346102412, 04041346102405
Basic UDI-DI
B-04041346102412, B-04041346102405
EMDN Code
Z12050404 Blood pressure holter recorders
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005735

Other devices from IEM GmbH

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 (2)

  • EUDAMED bf5462d7-c266-42e9-93e6-e589574af16c 61 fields · synced 25 Oct 2026
  • EUDAMED 04041346102405|B-04041346102405 61 fields · synced 18 May 2026