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Radius T 4776

by Masimo Corporation

Ref 4776Model Radius T

Radius T 4776 is a device classified as Class IIa in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-10843997016084), cleared under FDA 510(k) K203215 on 11 Jun 2021 and listed in FDA GUDID since 8 Oct 2021 (UDI-DI 10843997016084), active as of 25 Oct 2026.

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

CE MDD 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) K203215

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/MDD EUDAMED NumberB-10843997016084 Basic UDI-DI 10843997016084UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10843997016084 UDI-DI Date8 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK203215 Date11 Jun 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10843997016084 registered 6 Oct 2026 Active
  • FDA 510(k) K203215 decided 11 Jun 2021 Active
  • FDA GUDID UDI-DI 10843997016084 listed 8 Oct 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K203215
  2. Listed FDA GUDID 10843997016084
  3. Registered EUDAMED B-10843997016084

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Radius T
Generic name
Wireless patient thermometer, single-use
Model / reference
4776, Radius T
Primary DI / UDI-DI
10843997016084
Basic UDI-DI
B-10843997016084
510(k) Number
FDA product code
FLL
EMDN code
V0301010201 Contact digital thermometers (including probes)
GMDN term
Wireless patient thermometer, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.2910
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 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: Wireless patient thermometer, single-use

Cleared under the same submission (K203215)

Similar devices in this category

Other devices filed under CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES).

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Single use
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)