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Holter

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

Ref H3B, H3C, H12B

EMDN Z12050403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06958511500165 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 22 Oct 2026

Device Name
Holter
Model / Reference
H3B, H3C, H12B
Primary DI / UDI-DI
06958511500165, 06958511500301, 06958511500189
Basic UDI-DI
B-06958511500165, B-06958511500301, B-06958511500189
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa
Market of Registration
Italy
Poland
Romania

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 (3)

  • EUDAMED 05cd44b1-f5bb-469e-816a-bf5f34f96302 61 fields · synced 22 Oct 2026
  • EUDAMED 06958511500301|B-06958511500301 61 fields · synced 16 May 2026
  • EUDAMED 06958511500189|B-06958511500189 61 fields · synced 16 May 2026