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Electrocardiogragh

by Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD. China EUDAMED

Ref SE508

EMDN Z12050301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06948309089262 Basic UDI-DIDate8 May 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
SE508
Primary DI / UDI-DI
06948309089262
Basic UDI-DI
B-06948309089262
EMDN Code
Z12050301 General purpose electrocardiographs
Device Class
Class IIa
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000031019
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.

See all devices from Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 53e450b9-e56a-4379-9dc6-7cf82b5c147e 61 fields · synced 24 Oct 2026