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TruSignal SpO2 Disposable Sensor, Adult/Pediatric/Infant/Neonate, 0.5M

by GE Healthcare Finland Oy

Ref TS-AF-xx

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

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-00840682103176 Basic UDI-DI 00840682103176UDI-DIDate17 Dec 2021RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00840682103176 UDI-DI Date27 Jun 2016ListedStatusListed GUDID: not 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  • Withdrawn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  • European Union CE/MDD Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
TruSignal SpO2
Generic Name
Pulse oximeter probe, single-use
Device Name
TruSignal SpO2 Disposable Sensor, Adult/Pediatric/Infant/Neonate, 0.5M
Model / Reference
TS-AF-xx EUDAMED
TS-AF GUDID
Primary DI / UDI-DI
00840682103176
Basic UDI-DI
B-00840682103176
FDA Product Code
DQA, DPZ
EMDN Code
Z1203020285 Multi-parameter monitors - consumables
GMDN Term
Pulse oximeter probe, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2700, 870.2710
EU market of registration
Finland
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
TS-AF-xx
GUDID
TS-AF
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001176

Related devices

Category: General-purpose multi-parameter bedside monitor

Other devices from GE Healthcare Finland Oy

See all devices from GE Healthcare Finland Oy →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: 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
  • Manufacturing Date: No