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smartSET Adt CS-2

by Masimo Corporation

Ref 5504

Active European Union

CE MDR

Valid until

29 Apr 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number084399700000Z1T1B19V100J7 Basic UDI-DI 10843997019436UDI-DIDate27 Oct 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620149254-03 Active Supplemented

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    18 Dec 2023
    Expires
    29 Apr 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
smartSET Adt CS-1 Adhesive Sensor, 20/Box
Model / Reference
5504
Primary DI / UDI-DI
10843997019436
Basic UDI-DI
084399700000Z1T1B19V100J7
Unit of Use DI
00843997019439
EMDN Code
C900301 Pulse oximeter sensors
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000010641
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Masimo Corporation

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No