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Masimo SET 4321

by Masimo Corporation

Ref 4321Model uSpO2

Masimo SET 4321 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-00843997012652) and listed in FDA GUDID since 22 Aug 2023 (UDI-DI 00843997012652), active as of 25 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00843997012652 Basic UDI-DI 00843997012652UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997012652 UDI-DI Date22 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00843997012652 registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 00843997012652 listed 22 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00843997012652
  2. Registered EUDAMED B-00843997012652

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  • Withdrawn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

Trade name
uSpO2 Masimo SET Oximetry Cable EUDAMED
Masimo SET GUDID
Generic name
Rigid optical ureteroscope
Model / Ref / Catalog
4321, uSpO2
Primary DI / UDI-DI
00843997012652
Basic UDI-DI
B-00843997012652
FDA product code
DQA
EMDN code
Z1203020408 Pulse oximeters
GMDN term
Rigid optical ureteroscope
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Rigid optical ureteroscope

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

Other devices from Masimo Corporation

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Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)