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Patient monitor

by Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD. 15 variants

Ref AcuitsignM3

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06948309088944 Basic UDI-DI 06948309088944UDI-DIDate8 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
AcuitsignM3
Primary DI / UDI-DI
06948309088944
Basic UDI-DI
B-06948309088944
EMDN Code
Z1203020202 Transportable/portable multi–parameter patient monitors
Device Class
Class IIb
EU market of registration
Türkiye

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

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