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TruSignal Attachment Accessories

by GE Healthcare Finland Oy 8 variants

Ref TS-RTW-100

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

4 ongoing

This device is named in the recall

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/MDR EUDAMED Number8406821BUG00052GX Basic UDI-DI 00840682147309UDI-DIDate21 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682147309 UDI-DI Date3 Sep 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

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-2030-2023 FDA Class I initiated 19 May 2023
    • Ongoing Z-2028-2023 FDA Class I initiated 19 May 2023
    • Ongoing Z-2029-2023 FDA Class I initiated 19 May 2023
    • Ongoing Z-2027-2023 FDA Class I initiated 19 May 2023

    There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
TruSignal SpO2
Generic Name
Electrode/transducer strap, reusable
Device Name
TruSignal Attachment Accessories
Model / Ref / Catalog
TS-RTW-100
Primary DI / UDI-DI
00840682147309
Basic UDI-DI
8406821BUG00052GX
510(k) Number
FDA Product Code
DPZ
EMDN Code
Z1203020285 Multi-parameter monitors - consumables
GMDN Term
Electrode/transducer strap, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2710
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
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

  • Prescription Use

Other properties (23)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No