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Patient monitor

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

Active European Union

Ref h8Model H8

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06948309000069 Basic UDI-DIDate19 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
H8
Primary DI / UDI-DI
06948309000069
Basic UDI-DI
B-06948309000069
EMDN Code
Z1203020202 Transportable/portable multi–parameter patient monitors
Device Class
Class IIb
Market of Registration
Romania

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.

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Properties

  • 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