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ELI 280 Electrocardiograph

by Welch Allyn, Inc. United States EUDAMED

Ref ELI280-DCB-BAAAXModel 901132

EMDN Z12050302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00732094286922 Basic UDI-DIDate6 Oct 2026RegisteredStatusActive

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 24 Oct 2026

Device Name
Electrocardiograph
Model / Reference
901132, ELI280-DCB-BAAAX
Primary DI / UDI-DI
00732094286922
Basic UDI-DI
B-00732094286922
EMDN Code
Z12050302 Advanced diagnosis electrocardiographs
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000013394
Authorised representative
Welch Allyn Limited IE-AR-000000768

Other devices from Welch Allyn, Inc.

See all devices from Welch Allyn, Inc. →

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 00732094286922|B-00732094286922 61 fields · synced 24 Oct 2026