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Model 8000SL-WO2 Soft Sensor

by Nonin Medical, Inc.

Ref 114192-001Model MODEL 8000SL-WO2, SOFT SENSOR LARGE WO2, PHILIPS

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00849686050998 Basic UDI-DI 00849686050998UDI-DIDate10 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00849686050998 UDI-DI Date5 Apr 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Model 8000SL-WO2 Soft Sensor EUDAMED
Soft Sensor Large WO2 Model 8000SL-WO2 GUDID
Generic Name
Pulse oximeter probe, single-use
Model / Reference
MODEL 8000SL-WO2 EUDAMED
SOFT SENSOR LARGE WO2 EUDAMED
PHILIPS EUDAMED
114192-001 EUDAMED
8000SL-WO2 GUDID
Primary DI / UDI-DI
00849686050998
Basic UDI-DI
B-00849686050998
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 market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MODEL 8000SL-WO2, SOFT SENSOR LARGE WO2, PHILIPS
114192-001
GUDID
8000SL-WO2
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000008228
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Related devices

Category: Pulse oximeter probe, single-use

Other devices from Nonin Medical, Inc.

See all devices from Nonin Medical, Inc. →

Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No