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Bluetooth ECG

by Shenzhen ECGMAC Medical Electronics Co., Ltd. China EUDAMED

Ref PE-1204A

EMDN Z12050301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06958511500462 Basic UDI-DIDate27 Aug 2024RegisteredStatusActive

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
Bluetooth ECG
Model / Reference
PE-1204A
Primary DI / UDI-DI
06958511500462
Basic UDI-DI
B-06958511500462
EMDN Code
Z12050301 General purpose electrocardiographs
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000040172
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen ECGMAC Medical Electronics Co., Ltd.

See all devices from Shenzhen ECGMAC Medical Electronics Co., Ltd. →

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 89bd3e77-c60f-49ff-8716-f743dc9ea2c9 61 fields · synced 24 Oct 2026