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03 Sensor rS02 Large Adhesive Sensor 3756

by Masimo Corporation

Ref 3756

03 Sensor rS02 Large Adhesive Sensor 3756 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 084399700000Z4T1B10V100HT) and listed in FDA GUDID since 12 Oct 2017 (UDI-DI 10843997008416), active as of 23 Oct 2026.

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

CE MDR

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z4T1B10V100HT Basic UDI-DI 10843997008416UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10843997008416 UDI-DI Date12 Oct 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z4T1B10V100HT registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 10843997008416 listed 12 Oct 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10843997008416
  2. Registered EUDAMED 084399700000Z4T1B10V100HT

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
O3 Sensor EUDAMED
03 Sensor rS02 Large Adhesive Sensor GUDID
Generic name
Tissue saturation oximeter sensor, single-use
Device name
O3 Sensors
Model / reference
3756
Primary DI / UDI-DI
10843997008416
Basic UDI-DI
084399700000Z4T1B10V100HT
Unit of use DI
00843997008419
FDA product code
MUD
EMDN code
Z1203020406 Cerebral oximeters
GMDN term
Tissue saturation oximeter sensor, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2700
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: Tissue saturation oximeter sensor, single-use

Similar devices in this category

Other devices filed under GASEOUS EXCHANGE MONITORING INSTRUMENTS.

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Properties

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