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Wrist-Worn Pulse Oximeter

by Nonin Medical, Inc. 4 variants

Ref 114187-001Model MODEL 3150, WRIST-OX2, BLE, 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-00849686051025 Basic UDI-DI 00849686051025UDI-DIDate10 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00849686051025 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  • Withdrawn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
Wrist-Worn Pulse Oximeter EUDAMED
WristOx2 Model 3150 with Bluetooth Low Energy GUDID
Generic Name
Pulse oximetry telemetric monitoring system
Model / Reference
MODEL 3150 EUDAMED
WRIST-OX2 EUDAMED
BLE EUDAMED
PHILIPS EUDAMED
114187-001 EUDAMED
3150 GUDID
Primary DI / UDI-DI
00849686051025
Basic UDI-DI
B-00849686051025
510(k) Number
FDA Product Code
DQA
EMDN Code
Z1203020408 Pulse oximeters
GMDN Term
Pulse oximetry telemetric monitoring system
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 3150, WRIST-OX2, BLE, PHILIPS
114187-001
GUDID
3150
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

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

Other devices from Nonin Medical, Inc.

See all devices from Nonin Medical, Inc. →

Properties

  • Measuring Function
  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No
  • Expiration Date: No