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Upnmed

by Shenzhen UpnMed Equipment co., ltd

Ref U401-A, U401-B, U401-C, U401-D

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-U401HH Basic UDI-DI D-U401HHUDI-DIDate16 Nov 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
SpO2 Sensor
Model / Reference
U401-A, U401-B, U401-C, U401-D
Primary DI / UDI-DI
D-U401HH
Basic UDI-DI
B-U401HH
EMDN Code
Z1203020685 Vital signs telemetry instruments - consumables
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000019212
Authorised representative
R Sight B.V. NL-AR-000010445

Other devices from Shenzhen UpnMed Equipment co., ltd

  • SpO2 Sensor

    Class II

  • UpnMed

    Class IIb

  • UpnMed

    Class I

  • UpnMed

    Class I

  • UpnMed

    Class IIb

  • UpnMed

    Class IIb

See all devices from Shenzhen UpnMed Equipment co., ltd →

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