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Palmsat Handheld Oximeter

by Nonin Medical, Inc.

Ref 2500-06, 8073-001, 4521-000Model MODEL 2500, 8000Q2, MODEL 2500A CFG, PULSE OXIMETER W/ALARMS, MODEL 2500A, PULSE OXIMETER W/ALARMS

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-00833166000023 Basic UDI-DI Date10 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00833166000023 UDI-DI Date5 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  • Withdrawn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
Palmsat Handheld Oximeter EUDAMED
PalmSat Handheld Oximeter with 8000Q2 sensor GUDID
Generic Name
Pulse oximeter
Model / Reference
MODEL 2500, 8000Q2, 2500-06, MODEL 2500A CFG, PULSE OXIMETER W/ALARMS, 8073-001, MODEL 2500A, 4521-000, 2500
Primary DI / UDI-DI
00833166000023, 00849686090178, 00833166000016
Basic UDI-DI
B-00833166000023, B-00849686090178, B-00833166000016
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 2500, 8000Q2
2500-06
MODEL 2500A CFG, PULSE OXIMETER W/ALARMS
8073-001
MODEL 2500A, PULSE OXIMETER W/ALARMS
4521-000
GUDID
2500, 8000Q2
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
  • Expiration 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
  • Manufacturing Date: No