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Reusable Pulse Oximetry Sensor System

by Nonin Medical, Inc. 3 variants

Ref 7702-000, 1040-000, 0741-000Model MODEL 8000J-WO2, WRIST OX2 FLEX SENSOR, 953, NONIN ADULT FLEX SPO2 SENSOR, MODEL 8000J, ADULT FLEX SENSOR

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00833166003437 Basic UDI-DI Date11 Dec 2024RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
MODEL 8000J-WO2, WRIST OX2 FLEX SENSOR, 7702-000, 953, NONIN ADULT FLEX SPO2 SENSOR, 1040-000, MODEL 8000J, ADULT FLEX SENSOR, 0741-000
Primary DI / UDI-DI
00833166003437, 00833166004496, 00833166004717
Basic UDI-DI
B-00833166003437, B-00833166004496, B-00833166004717
EMDN Code
C900301 Pulse oximeter sensors
Device Class
Class IIb
EU market of registration
Netherlands

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

Other properties (10)

  • Sterile: 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