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Pulse Oximeter

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

Ref S8

EMDN Z1203020408

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06948309000175 Basic UDI-DIDate14 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 22 Oct 2026

Model / Reference
S8
Primary DI / UDI-DI
06948309000175
Basic UDI-DI
B-06948309000175
EMDN Code
Z1203020408 Pulse oximeters
Device Class
Class IIb
Market of Registration
Czechia

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 ba6e3036-522b-4479-86be-7969b0f1b0b3 61 fields · synced 22 Oct 2026