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Masimo W1 95080

by Masimo Corporation

Ref 95080

Masimo W1 95080 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 084399700000Z0T2A05V000FE), cleared under FDA 510(k) K232512 on 17 Nov 2023 and listed in FDA GUDID since 2 Mar 2024 (UDI-DI 00843997005364), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232512

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z0T2A05V000FE Basic UDI-DI 00843997005364UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997005364 UDI-DI Date2 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232512 Date17 Nov 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z0T2A05V000FE registered 27 Oct 2026 Active
  • FDA 510(k) K232512 decided 17 Nov 2023 Active
  • FDA GUDID UDI-DI 00843997005364 listed 2 Mar 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K232512
  2. Listed FDA GUDID 00843997005364
  3. Registered EUDAMED 084399700000Z0T2A05V000FE

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Masimo W1
Generic name
Wearable multiple vital physiological parameter monitoring system
Model / reference
95080
Primary DI / UDI-DI
00843997005364
Basic UDI-DI
084399700000Z0T2A05V000FE
510(k) Number
FDA product code
DPS
EMDN code
Z1203020202 Transportable/portable multi–parameter patient monitors
GMDN term
Wearable multiple vital physiological parameter monitoring system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2340
EU registration type
Standard device
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: Wearable multiple vital physiological parameter monitoring system

Cleared under the same submission (K232512)

and 6 more cleared under K232512

Similar devices in this category

Other devices filed under TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

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