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Lncs 3858

by Masimo Corporation

Ref 3858

Lncs 3858 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 8 Jun 2026 (Basic UDI-DI 084399700000Z1T1B04V105GD) with CE/MDR certificate 28620149254-03 valid until 29 Apr 2028, cleared under FDA 510(k) K160940 on 23 Nov 2016 and listed in FDA GUDID since 3 Sep 2020 (UDI-DI 10843997008867), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

29 Apr 2028

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

2 certificates

Certifier Intertek Medical Notified Body AB

510(k) K160940

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084399700000Z1T1B04V105GD Basic UDI-DI 10843997008867UDI-DIDate8 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10843997008867 UDI-DI Date3 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160940 Date23 Nov 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084399700000Z1T1B04V105GD registered 8 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K160940 decided 23 Nov 2016 Active
  • FDA GUDID UDI-DI 10843997008867 listed 3 Sep 2020 Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 28620149254-03 Active Supplemented

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    18 Dec 2023
    Expires
    29 Apr 2028
    Reason
    Add device or group
  • 28620149254-03 Active Supplemented Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    18 Dec 2023
    Expires
    29 Apr 2028
    Reason
    Add device or group

Timeline

5 dated events

  1. Cleared FDA 510(k) K160940
  2. Listed FDA GUDID 10843997008867
  3. Certificate issued EUDAMED 28620149254-03
  4. Registered EUDAMED 084399700000Z1T1B04V105GD
  5. Certificate expires EUDAMED 28620149254-03

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
Lncs Tfa-1 EUDAMED
Lncs GUDID
Generic name
Pulse oximeter probe, single-use
Device name
LNCS SET Disposable Sensors
Model / reference
3858
Primary DI / UDI-DI
10843997008867
Basic UDI-DI
084399700000Z1T1B04V105GD
Unit of use DI
00843997008860
510(k) Number
FDA product code
DQA
EMDN code
C900301 Pulse oximeter sensors
GMDN term
Pulse oximeter probe, 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: Pulse oximeter probe, single-use

Cleared under the same submission (K160940)

Similar devices in this category

Other devices filed under PULSE OXIMETER SENSORS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)