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FINGERTIP PULSE OXIMETER with 9590 BLUE, OXIMETER

by Nonin Medical, Inc.

Ref 8712-001, 110805-004Model MODEL 9590 BLUE, OXIMETER, MODEL 9590, OXIMETER - BLACK, INMETRO

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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-00833166009859 Basic UDI-DI Date11 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00833166009859 UDI-DI Date10 Sep 2024ListedStatusListed 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.

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  • Withdrawn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
FINGERTIP PULSE OXIMETER with 9590 BLUE, OXIMETER EUDAMED
Fingertip Pulse Oximeter EUDAMEDGUDID
Generic Name
Pulse oximeter
Model / Reference
MODEL 9590 BLUE, OXIMETER, 8712-001, MODEL 9590, OXIMETER - BLACK, INMETRO, 110805-004, 9590 BLUE
Primary DI / UDI-DI
00833166009859, 00849686051131
Basic UDI-DI
B-00833166009859, B-00849686051131
FDA Product Code
DQA
EMDN Code
Z1203020408 Pulse oximeters
GMDN Term
Pulse oximeter
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 9590 BLUE, OXIMETER
8712-001
MODEL 9590, OXIMETER - BLACK, INMETRO
110805-004
GUDID
9590 BLUE, OXIMETER
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
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No