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Holter Analysis Software

by Wuhan United Imaging Surgical Co., Ltd. China EUDAMED

Ref 88001269Model uMH WS300

EMDN Z12050392

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697478294software001FH Basic UDI-DIDate13 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
uMH WS300, 88001269
Primary DI / UDI-DI
06974782940936
Basic UDI-DI
697478294software001FH
EMDN Code
Z12050392 Electrocardiographs - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000032693
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Wuhan United Imaging Surgical Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 04de7d1b-8a04-4120-99d5-5b5e06f6b7ff 61 fields · synced 22 Oct 2026