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Masimo O3 Module

by Philips Medizin Systeme Böblingen GmbH

Ref 867184Model O3 Module

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884838086654 Basic UDI-DI 00884838086654UDI-DIDate16 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838086654 UDI-DI Date14 Oct 2021ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Patient monitoring system module, interfacing
Device Name
O3 Module
Model / Ref / Catalog
O3 Module, 867184, Masimo O3 Module
Primary DI / UDI-DI
00884838086654
Basic UDI-DI
B-00884838086654
FDA Product Code
DSI, DSJ, DSK, DXG, DXN, MHX
EMDN Code
Z12030280 Vital signs monitoring instruments - hardware accessories
GMDN Term
Patient monitoring system module, interfacing
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1025, 870.1100, 870.1110, 870.1435, 870.1130
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
O3 Module
867184
GUDID
Masimo O3 Module
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

Other devices from Philips Medizin Systeme Böblingen GmbH

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Properties

  • Measuring Function
  • Prescription Use
  • Serial Number

Other properties (19)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No