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rainbow 3797

by Masimo Corporation

Ref 3797

rainbow 3797 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 084399700000Z1T1B13V003G6), cleared under FDA 510(k) K182887 on 22 Mar 2019 and listed in FDA GUDID since 4 Sep 2020 (UDI-DI 00843997008976), 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) K182887

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 Number084399700000Z1T1B13V003G6 Basic UDI-DI 00843997008976UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997008976 UDI-DI Date4 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182887 Date22 Mar 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z1T1B13V003G6 registered 1 Jul 2026 Active
  • FDA 510(k) K182887 decided 22 Mar 2019 Active
  • FDA GUDID UDI-DI 00843997008976 listed 4 Sep 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182887
  2. Listed FDA GUDID 00843997008976
  3. Registered EUDAMED 084399700000Z1T1B13V003G6

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  • Withdrawn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
rainbow DCl-mini SC-200, Reusable Sensor (SpHb, SpO2 and SpMet), 200 SpHb Spot checks EUDAMED
rainbow GUDID
Generic name
Pulse Co-oximeter probe, reusable
Device name
rainbow DCI-mini Series Sensors
Model / reference
3797
Primary DI / UDI-DI
00843997008976
Basic UDI-DI
084399700000Z1T1B13V003G6
510(k) Number
FDA product code
DQA
EMDN code
C900301 Pulse oximeter sensors
GMDN term
Pulse Co-oximeter probe, reusable
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: Pulse Co-oximeter probe, reusable

Cleared under the same submission (K182887)

Similar devices in this category

Other devices filed under PULSE OXIMETER SENSORS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

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