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Handheld monitor

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

Ref SM50 EMDN Z1203020202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06948309002032 Basic UDI-DIDate16 Oct 2026RegisteredStatusActive

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  • Withdrawn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 · synced 23 Oct 2026

Model / Reference
SM50
Primary DI / UDI-DI
06948309002032
Basic UDI-DI
B-06948309002032
EMDN Code
Z1203020202 Transportable/portable multi–parameter patient monitors
Device Class
Class IIb
Market of Registration
France

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 06948309002032|B-06948309002032 61 fields · synced 23 Oct 2026