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iSpO2 Rx, USB-C, Pediatric

by Masimo Corporation

Ref 99031Model iSpO2

iSpO2 Rx, USB-C, Pediatric (99031) is a Class IIb device made by Masimo Corporation, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-00843997016681), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00843997016681 Basic UDI-DI 00843997016681UDI-DIDate27 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
iSpO2, 99031
Primary DI / UDI-DI
00843997016681
Basic UDI-DI
B-00843997016681
EMDN code
Z1203020408 Pulse oximeters
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

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

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

Other devices from Masimo Corporation

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Properties

  • Measuring function
Other properties (13, all answered No)