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Centroid 4302

by Masimo Corporation

Ref 4302

Centroid 4302 is a device classified as Class IIa in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI 084399700000Y0T1B11V100DK), cleared under FDA 510(k) K191882 on 22 Apr 2020 and listed in FDA GUDID since 22 Aug 2023 (UDI-DI 10843997012406), active as of 25 Oct 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191882

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Y0T1B11V100DK Basic UDI-DI 10843997012406UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10843997012406 UDI-DI Date22 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191882 Date22 Apr 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Y0T1B11V100DK registered 30 Sep 2026 Active
  • FDA 510(k) K191882 decided 22 Apr 2020 Active
  • FDA GUDID UDI-DI 10843997012406 listed 22 Aug 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191882
  2. Listed FDA GUDID 10843997012406
  3. Registered EUDAMED 084399700000Y0T1B11V100DK

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  • Withdrawn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
Centroid
Generic name
Ambulatory fall sensor
Model / Ref / Catalog
4302
Primary DI / UDI-DI
10843997012406
Basic UDI-DI
084399700000Y0T1B11V100DK
Unit of use DI
00843997012409
510(k) Number
FDA product code
MWI
EMDN code
Z12039085 Various instruments to support and monitor vital signs - consumables
GMDN term
Ambulatory fall sensor
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2300
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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Ambulatory fall sensor

Cleared under the same submission (K191882)

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)